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

By John Gever, Deputy Managing Editor, MedPage Today

Published: May 15, 2013

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.

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

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

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

Supreme Court skeptical of patent on breast cancer gene

Richard Wolf, USA TODAY, April 15, 2013

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.

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

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 

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