Tuesday, December 17, 2013

Check out new content on www.HelpWithCancer.org

I want to apologize for not posting here at Cancer News for two months.  Despite my inactivity here, lots has happened in the world of cancer therapy and research.

I'm a busy guy these days.  I just returned from New Orleans, where I covered the annual American Society of Hematology (ASH) meetings on behalf of the International Myeloma Foundation (IMF).  I'm now busy sorting through hundreds of abstracts and writing about what I heard and saw in the massive convention center on the banks of the Mississippi River.

My wife helps me organize and manage four different cancer related websites: www.HelpWithCancer.org, www.MultipleMyelomaBlog.com, www.MyelomaNews.com and this site, CancerNews.US.  But even with Pattie's help, I'm having trouble keeping up. 

To be honest, I'm facing some health related challenges these days, too.  My bone marrow cancer (multiple myeloma) has relapsed for the third time.  Between undergoing therapy, seeing specialists, driving to and from appointments and sitting in waiting rooms, I spend up to 15 hours a week dealing with my own health care.

So I've made a difficult decision.  This site has never been a priority.  A great idea, but not unlike someone who bellies up to a buffet only to learn that his eyes were bigger than his stomach.  I simply don't have time to do CancerNews.US justice.

So I've decided to focus on our five year old www.HelpWithCancer.org site instead.  Primarily focused on healthy living tips and how best to use anticancer supplements, I will try and include more general cancer related news on HWC now--the type of things I would have covered here.

I want to wish all of our readers my best.  Good luck to all of you with your cancer journey!

Feel good and keep smiling!  Pat

Monday, September 30, 2013

Old drugs bring new hope to lung cancer patients

Yes, I wish researchers could develop new classes of anti-cancer drugs.  But going back and finding new uses for existing medications saves everyone a lot of money.  Check this out:

Could Antidepressant Combat Lethal Lung Cancer?

Little-used depression drug shows early promise in lab, mice studies

September 27, 2013

FRIDAY, Sept. 27 (HealthDay News) -- An older and little-used class of antidepressants may help combat a particularly deadly form of lung cancer, according to a new study.

Using a unique computer program, researchers from the Stanford University School of Medicine identified tricyclic antidepressants as a potential treatment for small cell lung cancer. This class of drugs was introduced decades ago and is still approved for use in the United States, but has been supplanted by newer antidepressants with fewer side effects.

Follow-up experiments showed that the tricyclic antidepressant called imipramine (Tofranil), was effective against human small cell lung cancer cells grown in the laboratory and growing as tumors in mice. The drug activated a self-destruction pathway in the cancer cells and slowed or blocked the spread of cancer in mice.
Imipramine maintained its effectiveness regardless of whether the cancer cells had previously been exposed, and become resistant, to traditional chemotherapy treatments, according to the study, which was published online Sept. 27 in the journal Cancer Discovery.

Because tricyclic antidepressants already have U.S. Food and Drug Administration approval for use in people, the Stanford team was quickly able to launch a clinical trial to test imipramine in patients with small cell lung cancer and certain other types of cancer. They are currently recruiting patients for the phase-2 trial.
"We are cutting down the decade or more and the $1 billion it can typically take to translate a laboratory finding into a successful drug treatment to about one to two years and spending about $100,000," study co-senior author Dr. Atul Butte, director of the Center for Pediatric Bioinformatics at Lucile Packard Children's Hospital at Stanford, said in a university news release.

"The five-year survival for small cell lung cancer is only 5 percent," study co-senior author Julien Sage, an associate professor of pediatrics, said in the news release. "There has not been a single efficient therapy developed in the last 30 years. But when we began to test these drugs in human cancer cells grown in a dish and in a mouse model, they worked, and they worked, and they worked."

Another drug, an antihistamine called promethazine (Phenergan), also exhibited the ability to kill cancer cells, according to the researchers.

More information
The U.S. National Cancer Institute has more about small cell lung cancer.
Copyright © 2012 HealthDay. All rights reserved.

Monday, September 9, 2013

Celgene's breast cancer drug approved for pancreatic cancer now, too

How tough is pancreatic cancer to treat?  FDA approval of existing cancer drug, Abraxane, based on anemic overall survival (OS) stat improvement of a meager 1.8 months.  Here's a short article about it, courtesy of HealthDay News:

Abraxane Approved for Late-Stage Pancreatic Cancer


Previously sanctioned for cancers of the lung and breast


FRIDAY, Sept. 6 (HealthDay News) -- U.S. Food and Drug Administration approval for Abraxane (paclitaxel) has been expanded to include advanced pancreatic cancer, the agency said Friday in a news release.

The agency previously approved the chemotherapy drug to treat cancers of the lung and breast.
Some 45,220 people are expected to be diagnosed with pancreatic cancer this year, and an estimated 38,460 will die from it, the FDA said.

Pancreatic cancer is the fourth-leading cause of cancer death. Surgery is the only way to permanently remove pancreatic cancer, but it's usually too late for surgery by the time most cases are identified, the agency said.

Abraxane's safety and effectiveness in treating pancreatic cancer were evaluated in clinical trials involving 861 people. Those treated with Abraxane and another chemotherapy drug, gemcitabine, lived an average of 1.8 months longer than those treated with gemcitabine alone.

Common side effects of the drug combination included a drop in white blood cells and blood platelets, fatigue, nerve damage in the extremities, vomiting, diarrhea and fever.
Abraxane is marketed by Celgene, based in Summit, N.J.

1.8 months?  Hard to say if I would endure side effects like those for such a short return on my quality of life "investment."

I have an acquaintance battling pancreatic cancer now. Doing better than Mayo Clinic docs expected.  Original six month prognosis may turn into a year or more.  Not sure if he is using this drug as part of his ongoing chemotherapy regimen...

Tough stuff!  Feel good and keep smiling!  Pat

Thursday, September 5, 2013

Valerie Harper Cancer Update

I watched Valerie Harper last night on "Hot in Cleveland."  Sort of a Mary Tyler Moore TV show reunion. 

Here's an update on her progress fighting terminal brain cancer.  Sounds like she's doing pretty well!

Valerie Harper's Terminal Brain Cancer "Pretty Close to a Remission," Says Her Doctor—Watch Now

by Rebecca Macatee Thu., Aug. 29, 2013

Valerie Harper went public with her terminal brain cancer diagnosis in March 2013, but five months later, things are looking hopeful for the beloved Mary Tyler Moore star.

In fact, according to her doctor, the 74-year-old actress is "getting pretty close to remission." But, as Dr. Jeremy Rudnick explained in an interview excerpted on Today, Thursday, Aug. 29,  the rare form of cancer will still be fatal.

"It defies the odds," he explained of Valerie's response to chemotherapy as well as alternative treatments like acupuncture, but he explained that her leptomeningeal carcinomatosis will "develop resistance to the therapy." Meaning? "It's not a matter of if (the cancer becomes resistant)," said Dr. Rudnick, "it's a matter of when."

NEWS: Valerie Harper begins work on TV movie

"Going from having three months to live, or less; we're into our sixth month, and now there's even hope beyond right now we're looking at—" he started.

And Harper interjected cheerily, "We're looking at Christmas!"

"Life is about buying time," her physician said.

Harper agreed, saying "Exactly…That's what I always say."

Lots of great video; go to:

http://www.eonline.com/news/453583/valerie-harper-s-terminal-brain-cancer-pretty-close-to-a-remission-says-her-doctor-watch-now

We wish her all the best.  Feel good and keep smiling!  Pat

Thursday, August 8, 2013

Onyx Pharmaceutical 2nd Quarter Financials:

NO LINK AVAILABLE

Onyx Pharmaceuticals Reports Second Quarter 2013 Financial Results

Total Revenue More Than Doubles to $153 Million vs. Prior Year

SOUTH SAN FRANCISCO, CA--(Marketwired - August 08, 2013) - Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the second quarter 2013 and provided a business update on Kyprolis® (carfilzomib) for Injection, Nexavar® (sorafenib) tablets and Stivarga® (regorafenib) tablets.

"Accelerating revenue from each of our products, coupled with strategic investment to unlock the value of Kyprolis, provides a compelling platform for the current and future growth of Onyx," said Tony Coles, M.D., chairman and chief executive officer of Onyx. "With our Phase 3 program for Kyprolis across all lines of multiple myeloma therapy, we are committed to expanding the label globally, and we have a clear strategy to enable a filing in Europe in the second half of 2014, pending positive results from both ASPIRE and FOCUS. Important commercial, clinical, and regulatory momentum across the business continues to drive Onyx's value creation as we become an emerging global oncology leader."

For the second quarter of 2013, Onyx reported total revenue of $153.0 million and a non-GAAP net loss of $29.0 million, or $0.40 per diluted share. On a GAAP basis, Onyx reported a net loss of $53.2 million, or $0.73 per diluted share, for the second quarter 2013. A description of the non-GAAP calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."

Revenue
Total revenue of $153.0 million for the second quarter of 2013 represented a 110% increase from total revenue of $72.7 million for the comparable period in 2012.
  • Revenue from the Nexavar collaboration agreement with Bayer for the second quarter of 2013 was $81.8 million as compared to $72.7 million for the comparable period in 2012. The increase in revenue from collaboration was primarily due to sales growth in the United States and Asia Pacific regions as well as lower expenses.
  • Kyprolis net sales for the second quarter of 2013 were $61.0 million, representing orders shipped to and received by customers such as physician offices and hospitals. In addition, Onyx recorded deferred revenue of $10.0 million as of June 30, 2013, representing Kyprolis inventory at distributors which had not yet shipped to physician offices and hospitals.
  • Stivarga royalty revenue was $10.2 million for the second quarter of 2013. Onyx receives a 20% royalty on global net sales of Stivarga in jurisdictions that have received commercial marketing approval. Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States.
Operating Expenses
Non-GAAP cost of goods sold was $1.8 million for the second quarter of 2013. Cost of goods sold related to sales of Kyprolis is not representative of Onyx's future expectations of cost of goods sold because certain product costs associated with Kyprolis sales in the second quarter of 2013 were charged to research and development expense in periods prior to approval on July 20, 2012. On a GAAP basis, cost of goods sold was $2.0 million for the second quarter of 2013.

Non-GAAP research and development expense was $99.4 million for the second quarter of 2013, compared to $73.6 million for the same period in 2012. Higher research and development expense between periods was primarily due to the global development of Kyprolis, particularly the ongoing Phase 3 ENDEAVOR trial, and start-up activities associated with the front-line CLARION study, as well as oprozomib development expense, which were partially offset by lower Kyprolis Phase 3 FOCUS and ASPIRE trial expense. On a GAAP basis, research and development expense was $102.8 million for the second quarter of 2013, compared to $76.4 million for the same period in 2012.

Non-GAAP selling, general and administrative expense was $78.4 million for the second quarter of 2013, compared to $40.7 million for the same period in 2012. Higher selling, general and administrative expense between periods was primarily related to the increased headcount following the hiring of the field sales force associated with the commercial launch of Kyprolis in the United States and adding select capabilities internationally. On a GAAP basis, selling, general and administrative expense was $87.5 million for the second quarter of 2013, compared to $48.9 million for the same period in 2012.

Onyx recorded amortization expense of $5.2 million for the second quarter of 2013, which reflected the amortization of its finite-lived intangible asset, which was acquired in the 2009 acquisition of Proteolix, Inc.

Cash, Cash Equivalents and Marketable Securities
On June 30, 2013, cash, cash equivalents and current and non-current marketable securities were $755.9 million, compared to $492.8 million at December 31, 2012. The increase was primarily due to net proceeds of approximately $352 million received from a public offering of 4.4 million shares of common stock, completed in January 2013, offset primarily by net operating expenses.

Six-Month Results
Total revenue was $298.5 million and $144.7 million for the six months ended June 30, 2013 and 2012, respectively. Revenue from the Nexavar collaboration agreement with Bayer was $152.1 million and $144.7 million for the six months ended June 30, 2013 and 2012, respectively. Kyprolis net sales were $125.0 million for the six months ended June 30, 2013. Stivarga royalty revenue was $19.3 million for the six months ended June 30, 2013. Non-GAAP net loss for the six months ended June 30, 2013 was $42.8 million or $0.59 per diluted share, compared to $87.1 million, or $1.36 per diluted share for the same period in 2012. For the six months ended June 30, 2013, on a GAAP basis Onyx recorded a net loss of $86.8 million, or $1.20 per diluted share, compared with a net loss of $162.3 million, or $2.54 per diluted share, for the same period in 2012.

Non-GAAP Financial Measures
This press release and the reconciliation table included herein includes the following non-GAAP financial measures: non-GAAP net income (loss), non-GAAP net income (loss) - diluted, non-GAAP net income (loss) per share, non-GAAP net income (loss) per share - diluted, non-GAAP cost of goods sold, non-GAAP research and development expense, non-GAAP selling, general and administrative expense and non-GAAP operating expenses. A description of the non-GAAP calculations and reconciliation to the comparable GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."

Onyx management uses these non-GAAP financial measures to monitor and evaluate our operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. Onyx management believes the non-GAAP information is useful for investors by offering the ability to better identify trends in our business and better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all items of income and expense that affect Onyx. These non-GAAP financial measures are not prepared in accordance with, and should not be considered in isolation of, or as an alternative to, measurements required by GAAP.

Management Conference Call Today
Onyx will host a webcast and conference call with management to discuss second quarter 2013 financial results, as well as provide a general business overview, today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).
To access a live audio webcast of the conference call, log onto the Company's website at: http://www.onyx.com/investors/event-calendar
To access the live conference call, dial 847-585-4405 and use the passcode 35393849#. A replay of the call will be available on the Onyx website, or by dialing 630-652-3042 and using the passcode 35393849# beginning approximately one hour after the teleconference concludes through August 22, 2013.

About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The Company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the Company's website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.

Tuesday, August 6, 2013

Cancer rates in Australia among highest in the world

I didn't realize that cancer rates are so high in Australia.  Obesity is mentioned as one cause, but bet the sun has something to do with it, too.

Click on the headline link below to read all about it:

WHO cancer rate data show's Australia has worst in the world

Thursday, July 25, 2013

African Americans at bottom of statistical cancer heap

African Americans continue to lag behind in most cancer survival statistics.  Breast cancer and multiple myeloma (bone marrow cancer) are two of the worst.  Seems to be a combination of economics, lack of access to specialists in the inner city; with maybe a cultural aspect thrown-in.  The bottom line:  Both government and industry need to try and get it straightened-out!

Why breast cancer kills more black women: They’re sicker


July 23, 2013


Karen Jackson, founder and CEO of Sisters Network Inc, believes African-American women need more education about breast cancer.

Doctors and policymakers have known for years that African-American women are more likely to die of breast cancer than white women. Studies have offered all sorts of clues – there may be genetic differences, there may be disparities in getting medical care, black women may get inferior treatment, and blacks may simply avoid doctors more.

This latest study, done using a new method, shows not only that the differences are still there, years after experts first began to notice them -- it also shows that black women are in poorer shape overall than whites when they are diagnosed.

“They come in sicker, with more advanced disease and more chronic conditions,” says Dr. Jeffrey Silber of the Children’s Hospital of Philadelphia, who led the study published in the Journal of the American Medical Association. “The disparity looks to be unchanged over the past few decades.”

Read more by clicking on the link below:

http://www.nbcnews.com/health/why-breast-cancer-kills-more-black-women-theyre-sicker-6C10722276

Feel good and keep smiling!  Pat

Friday, July 19, 2013

Say it ain't so; Omega 3s may not be as healthy as previously thought

This is last week's news, but that doesn't make it any less important. Check-out this Time.com headline recently:

Hold the salmon: omega-3 fatty acids linked to higher risk of cancer


Here's the link:

 http://www.cnn.com/2013/07/12/health/salmon-cancer-time

Still, keep in mind that 43% or even 71% of an incredibly small percentage doesn't result in a very high risk after all.  And compared to the benefit of consuming Omega 3's for heart health, I'm not sure men should avoid fish oil supplements.  Seems to me the rewards far outweigh the risks.  Maybe like all supplements, just don't go overboard?  But eating salmon twice a week is absolutely good for you!  Now fish oil capsules; who knows?  But I have trouble believing that one or two fish oil capsules a day is going to cause anyone to develop cancer.

Feel good and keep smiling!  Pat

Monday, July 8, 2013

I'M BACK!

No posts since May?  If this were a personal blog and I were writing about my own cancer (which I do at HelpWithCancer.org (HWC) and MultipleMyelomaBlog.com (MMB) daily, that would be a mistake.  A big mistake!

I feel that anyone who blogs for any reason other than to journal on a personal medical website like CaringBridge--and probably even then--owes his or her readers to post on a reliable schedule.  It may only be once a week or even once a month.  But if a blogger posts several blogs a day and then stops for a week - without explanation - that can be a scary thing for family members, friends and followers.  It's my pet blogging peeve!  I have blogged every day for over three years--and every other day or so for several years before that--and plan to continue until my lovely wife places my ashes on the mantel!

But this isn't a personal site as such.  It's more informational.  A sight to pass-along cancer news from an experienced patient's perspective.  So I took a few months off to get my head straight and have my right hip replaced. 

But I'm back and promise not to ever leave such a cavernous gap in service again!  Instead, I may decide to incorporate CancerNews.US into my HWC site; that is if my friend and tech volunteer, Robb, can figure-out how to integrate two different blogging platforms.

All that aside, I'm back and ready to pass-along important cancer related news; important research updates, sensational celebrity cancer related news and everything in-between. 

In the meantime, you may want to check-out yesterday's HWC post about the hottest news in cancer treatment: immunotherapies.  Here's the link:

http://helpwithcancer.org/2013/07/could-immunotherapy-make-chemo-obsolete-dont-hold-your-breath.html

Feel good and keep smiling!  Pat

Friday, May 17, 2013

New prostate cancer drug, Xofigo, gains FDA fast-track approval earlier this week

Only 3 months benefit?  More discouraging than encouraging, don't you think?


Bayer's Xofigo for Prostate Cancer Gets Fast Approval

SILVER SPRING, Md. -- The FDA has approved radium-223 dichloride (Xofigo) for treating bone metastases from castration-resistant prostate cancer, the agency said Wednesday. Its specific indication is for men with symptomatic, late-stage, castration-resistant prostate cancer with metastases in bone but not other organs, following conventional medical and/or surgical therapy to reduce testosterone levels.

The approval was based primarily on a placebo-controlled trial in 809 patients that showed a median overall survival time of 14 months in those receiving the drug compared with 11.2 months in the placebo group. Patients in the trial also received other treatments judged to be clinically appropriate on an individual basis.
Radium-223 dichloride binds chemically to minerals in bone "to deliver radiation directly to bone tumors, limiting the damage to surrounding tissues," said Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products, in a statement.

The approval, made through the agency's priority review process, came 3 months before the FDA's Aug. 14 deadline to render a decision.

Adverse effects seen with the drug in clinical trials included nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot, the FDA said. Hematologic effects included anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

The drug was developed by Bayer Pharmaceuticals, Wayne, N.J.

Monday, May 6, 2013

Some good news on the celebrity cancer front...

Not sure if he can legitimately claim that pot cured his prostate cancer, but leave it to Tommy to try:

Tommy Chong Prostate Cancer-Free, Comedian Reports

Posted on May 6, 2013 - SFgate.com

Activist and comedian Tommy Chong claims he is cancer-free today on website
Celebstoner.com

“I brought my PSA numbers down drastically and eliminated the cancer threat… That’s right, I kicked cancer’s ass! So the magic plant does cure cancer with the right diet and supplements. I’m due for another blood test, MRI, etc., but I feel the best I’ve felt in years.”

Chong announced last year that he had been diagnosed with prostate cancer, a severe but treatable form or cancer if caught early.  Chong reports avoiding expensive, experimental treatments for dietary change, supplements and hemp oil. 

“With the diet, the supplements and the hash oil, plus a session with a world-renowned healer, Adam Dreamhealer, I’m cancer-free,” he wrote. And now for a celebration joint of the finest Kush.”

Doctors define a cancer treatment as a “cure” if a patient lives five years without the return of the cancer.

Feel good and keep smiling; Tommy is!  Pat

Friday, April 26, 2013

Former Notre Dame basketball coach diagnosed with bladder cancer

As our society ages, more and more TV and movie celebrities have been and will be diagnosed with cancer.  ESPN released this unfortunate news last night.  Here's Sports Illustrated's take:

ESPN’s Digger Phelps diagnosed with bladder cancer

ESPN college basketball analyst Digger Phelps has been diagnosed with bladder cancer, the network announced Thursday night.

The network said that Phelps has undergone surgery to treat the cancer and will begin follow-up treatment next week near his home in South Bend, Ind.  Phelps said in a statement that ”he and his family appreciate your thoughts and prayers as he prepares for the 2013-2014 college basketball season,” according to ESPN.

Phelps, 71, has been a major face of college basketball for more than four decades. He coached the Notre Dame men’s basketball team from 1971-91, where he memorably led the Irish to an upset over No. 1 UCLA record 88-game winning streak. He has been an ESPN analyst since 1993.

I'm sure I join all of our readers here, at HWC, MMB and MyelomaNews.com wishing Digger well.  

Sometimes it's hard, but feel good and keep smiling!  Pat

Wednesday, April 17, 2013

Click-on the headline link below to read all about it...

Supreme Court skeptical of patent on breast cancer gene

A decision against the patent would be a victory for competing geneticists and researchers as well as breast cancer advocacy groups. But a compromise may be more likely.

Friday, April 12, 2013

Pfizer's experimental breast cancer drug gets fast-tracked by FDA

Last post had to do with ovarian cancer.  This one breast cancer.  Baby steps helping women with cancer issues.  BRAVO!

Breast cancer drug gets breakthrough label

Linda A. Johnson, Associated Press

TRENTON, N.J. — Pfizer Inc. said Wednesday that its experimental pill for advanced, often deadly breast cancer has been designated as a breakthrough therapy by the Food and Drug Administration.
Pfizer shares jumped nearly 3% following the news.

The breakthrough designation, created under legislation enacted last summer to fund and improve operations of the FDA, is meant to speed up development and review of experimental treatments that are seen as big advances over existing therapies for serious diseases. Pfizer is working with the agency to determine exactly what research results it will need to apply for approval of the drug.

Palbociclib is being evaluated as an initial treatment for the biggest subgroup of postmenopausal women whose breast cancer is locally advanced or has spread elsewhere in the body. About 60% of women with such advanced breast cancer have tumors classified as ER+, or estrogen-receptor positive, but HER2-, or lacking an excess of the growth-promoting protein HER2.

Estrogen-receptor positive tumors have proteins inside and on the surface of their cells to which the estrogen hormone can attach and then fuel growth of cells. These tumors tend to grow slowly and can be fought with drugs that block estrogen's effects.

Meanwhile, about 80% of breast cancer tumor cells are HER2 negative. That means that unlike HER2 positive tumors, they don't produce too much of the HER2 protein, which makes tumors grow and spread more aggressively than in other breast cancer types.

New York-based Pfizer is currently running a late-stage study of palbociclib at multiple centers, comparing its effects when used in combination with letrozole with the effects of letrozole alone.  Letrozole, sold under the brand name Femara for about the past 15 years, is a pill that works by inhibiting aromatase. That's an enzyme in the adrenal glands that makes estrogen.

According to Pfizer, palbociclib targets enzymes called cyclin dependent kinases 4 and 6. By inhibiting those enzymes, the drug has been shown in laboratory studies to block cell growth and suppress copying of the DNA of the cancer cells. Pfizer, which has made research on cancer medicines a priority in recent years, also is testing palbociclib as a treatment for other cancers.

I'm not familiar with this new "breakthrough designation."  I am familiar with "fast tracking" a drug.  Sounds like the same type of thing...

Feel good and keep smiling!  Pat

Sunday, April 7, 2013

New immunotherapy shows very good response in new ovarian cancer study

Funny I would be getting this news via China!  Its the new world we live in... 

 

Vaccine shows promise for ovarian cancer in US

China Daily

WASHINGTON - US scientists have developed an experimental vaccine against advanced ovarian cancer that triggers anti-tumor immune responses using cells made from patients' own tumor.

The vaccine provoked a positive response in 61 percent of woman with stage 3 or 4 ovarian cancer, according to a report presented Saturday at the American Association for Cancer Research annual meeting in Washington.

The University of Pennsylvania researchers first isolated immune cells called dendritic cells from patient's blood. They then created individualized vaccines by exposing each patient's dendritic cells to her own tumor tissue that had been collected during surgery. They found 19 out of 31 patients clinical benefit after vaccine treatment and developed an antitumor immune response.

Of these 19 patients, eight had no measurable disease at the end of the study and remained on maintenance vaccine therapy. One patient of the eight patients remained disease-free for 42 months following vaccine treatment, they said. While vaccination therapy alone showed about a 61-percent clinical benefit, said lead author Lana Kandalaft, the combination of both therapies showed about a 75-percent benefit.

Both treatments were given in conjunction with bevacizumab, a drug that controls blood vessel growth.
"We offer patients with ovarian cancer a potential therapy with minor side effects and a good quality of life," Kandalaft said. The researchers said they will continue to work to improve the vaccine platform to further enhance its efficacy.



I asked Pat what he thought about this.  He felt that these were impressive results compared to those he covers for other cancers.


Feel good and keep smiling!  Pat 

Tuesday, March 26, 2013

BREAKING NEWS: Japan approves use of Onyx metastatic colorectal cancer drug six months after FDA does the same here in U.S.



I wouldn't normally share news like this on CancerNews.US.  Not because it isn't important--it is--but because it isn't flashy.  Onyx Pharmaceuticals manufacturers a new multiple myeloma (bone cancer) drug so I have contacts at the company.  I was going to disregard it, until I realized it could be very instructional.  Note very little information about how effective Stivarga is, but lots of information about possible side effects and complications.

Such is the world we live in.  In the world of chemotherapy, the medicine can end-up being worse than the cancer. 

The Pharma Times' Selina McCee reported this one hour ago:

Bayer's Stivarga has been approved for the treatment of patients with unresectable, advanced/recurrent CRC, after data from the pivotal Phase III CORRECT study showed a statistically significant improvement in overall survival and progression-free survival compared to placebo in patients whose disease had progressed despite prior treatment.

What does "significant improvement" mean?  According to the FDA, in this case:

Results showed patients who took Stivarga had a delay in tumor growth (progression-free survival) that was, on average, 3.9 months later than patients who were given placebo.

The FDA approved Stivarga's use last September here in the U.S.  I have no agenda here.  But as a cancer patient, this news--and these numbers--don't exactly leave me feeling all warm and fuzzy.  Check-out the list of possible complications in the press release below and draw your own conclusions.


Bayer's Stivarga(R) (regorafenib) Tablets Approved in Japan

WAYNE, NJ and SOUTH SAN FRANCISCO, CA--(Marketwire - March 25, 2013) - Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Stivarga® (regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC). 

In September 2012, Stivarga was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It was approved by the U.S. FDA for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate in February 2013. 

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology. 

The approval of Stivarga by the MHLW is based on data from the international multicenter pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial which evaluated regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with mCRC, whose disease has progressed after approved standard therapies. The CORRECT study included 20 sites in Japan. 

About Stivarga (regorafenib)
In the United States, Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 


Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.(1)
For full U.S. prescribing information, including BOXED WARNING, visit www.stivarga-us.com

Important U.S. Safety Information for Stivarga® (regorafenib) Tablets
 
WARNING: HEPATOTOXICITY
  • Severe and sometimes fatal hepatotoxicity has been observed in clinical trials.
  • Monitor hepatic function prior to and during treatment.
  • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
Severe drug-induced liver injury with fatal outcome occurred in 0.3% of 1200 STIVARGA-treated patients across all clinical trials. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm. 

Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue STIVARGA, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis. 

STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with STIVARGA vs 8% and 3% with placebo in mCRC and GIST patients, respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%) STIVARGA-treated patients and involved the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin. 

STIVARGA caused an increased incidence of hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and severe rash, frequently requiring dose modification. The overall incidence was 45% and 67% with STIVARGA vs 7% and 12% with placebo in mCRC and GIST patients, respectively. Incidence of Grade 3 HFSR (17% vs 0% in mCRC and 22% vs 0% in GIST), Grade 3 rash (6% vs < 1% in mCRC and 7% vs 0% in GIST), serious adverse reactions of erythema multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson syndrome (0.2% vs 0% in mCRC) was higher in STIVARGA-treated patients. Toxic epidermal necrolysis occurred in 0.17% of 1200 STIVARGA-treated patients across all clinical trials. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity. 

STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC and 59% vs 27% in GIST with STIVARGA vs placebo, respectively). Hypertensive crisis occurred in 0.25% of 1200 STIVARGA-treated patients across all clinical trials. Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension. 

STIVARGA increased the incidence of myocardial ischemia and infarction (1.2% with STIVARGA vs 0.4% with placebo). Withhold STIVARGA in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia. 

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurred in 1 of 1200 STIVARGA-treated patients across all clinical trials. Confirm the diagnosis of RPLS with MRI and discontinue STIVARGA in patients who develop RPLS. 

Gastrointestinal perforation or fistula occurred in 0.6% of 1200 patients treated with STIVARGA across clinical trials. In GIST, 2.1% (4/188) of STIVARGA-treated patients developed gastrointestinal fistula or perforation: of these, 2 cases of gastrointestinal perforation were fatal. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula. 

Treatment with STIVARGA should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. STIVARGA should be discontinued in patients with wound dehiscence. 

STIVARGA can cause fetal harm when administered to a pregnant woman. Use effective contraception during treatment and up to 2 months after completion of therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. 

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from STIVARGA, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 

The most frequently observed adverse drug reactions ( ≥ 30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).
The most frequently observed adverse drug reactions ( ≥ 30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%). 

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer's oncology franchise now includes two oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. 


About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases. 


About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.

STIVARGA® is a trademark of Bayer®. Bayer® and the Bayer Cross® are registered trademarks of Bayer. 

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 


This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding results of clinical development, regulatory processes, safety and commercial potential of Stivarga (regorafenib). These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: competition; failures or delays in clinical trials or the regulatory process; Onyx or Bayer, as the case may be, may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for Stivarga; market acceptance and the rate of adoption of Stivarga; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Stivarga; and government regulation; Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission, as updated by Onyx's subsequent Quarterly Reports on Form 10-Q, under the heading "Risk Factors" for a more detailed description of these and other risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
References: 

1. STIVARGA U.S. Prescribing Information, February 2013. 

I write about taking "baby steps" in oncology.  Seems to me these are "baby, baby steps."

Feel good and keep smiling!  Pat