Sunday, October 28, 2012

More bad news for African Americans with cancer

Can't African Americans get a break?  Here is another example of how cancer hits them harder than most...

African-American Women: Breast Cancer More Deadly?

Oct. 28, 2012 -- African-American women may be more likely to die of breast cancer than women of other races, especially in the first few years after the diagnosis, according to new research.

As to why, there are no clear answers yet, but the emphasis on vigilant care is clear for African-American women.

"Black women were almost 50% more likely to die compared to white women within the first three years since breast cancer was diagnosed," says researcher Erica Warner, ScD, MPH, a postdoctoral research fellow at the Harvard School of Public Health.

That higher risk of death was driven by African-American women who had estrogen receptor-positive tumors, she found. These tumors are usually more treatable than other types.

Asian women, in comparison to whites or African-Americans, had a lower risk of dying from breast cancer, she found.

Warner presented the study today at the American Association for Cancer Research conference on cancer health disparities in San Diego...

Read more of this WebMD story by CLICKING HERE.

Feel good and keep smiling!  Pat

 

Friday, October 12, 2012

Celgene's chemo drug, Abraxane, now FDA approved for non-small cell lung cancer patients

This is far from a cure, but important baby steps nonetheless...

FDA APPROVES ABRAXANE® FOR THE FIRST-LINE TREATMENT OF ADVANCED NON-SMALL CELL LUNG CANCER
                                                                                  
Approval Based on Significantly Improved Overall Response Rates
in all Patients Regardless of Histology

Adds a New Therapeutic Option for Patients with Lung Cancer,
the Leading Cause of Cancer Deaths in the United States


SUMMIT, NJ – (Oct. 11, 2012) – Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Dr. Mark A. Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of ABRAXANE phase II and phase III lung cancer trials. “The FDA approval of ABRAXANE is exciting  for healthcare professionals because it offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years.”

The ABRAXANE sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study where patients with advanced non-small cell lung cancer (NSCLC) received either ABRAXANE (100mg/m2) weekly plus carboplatin (AUC=6) every three weeks (n=521) or paclitaxel (200mg/m2) every three weeks plus carboplatin (AUC=6) (n=531). The study met its primary end-point demonstrating a statistically significantly higher overall response rate for patients in the ABRAXANE arm compared to those in the paclitaxel arm (33% vs 25%).
In the phase III study, ABRAXANE demonstrated a higher overall response rate as compared to paclitaxel for squamous cell carcinoma (41%  vs. 24%) and large cell carcinoma (33% vs. 15%).  ABRAXANE achieved a similar overall response rate to paclitaxel in patients with carcinoma/adenocarcinoma (26% vs. 27%).

The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin for NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
Additional regulatory submissions have been filed in Japan, Australia and New Zealand with anticipated decisions in 2013.

This approval marks the second indication for ABRAXANE in the United States. In the United States, ABRAXANE was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.  

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 

ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

Tuesday, October 2, 2012

Indianapolis Colts Coach diagnosed with acute promyelocytic leukemia

Colts coach Chuck Pagano battling leukemia

BREAKING NEWS: Breast cancer drug, Abraxane, also works in patients with advanced melanoma



A drug company contact I know emailed me this news today:

ABRAXANE MEETS PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL IN PHASE III CHEMOTHERAPY-NAÏVE METASTATIC MELANOMA STUDY


BOUDRY, Switzerland – (Oct. 2, 2012) – Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced results of its phase III, randomized, international study (CA033) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in chemotherapy-naïve patients with metastatic melanoma. In the study, the primary endpoint was met with patients receiving ABRAXANE demonstrating a statistically significant improvement in progression-free survival compared to patients receiving dacarbazine (DTIC) chemotherapy.

The safety profile of ABRAXANE observed in the CA033 study is consistent with other ABRAXANE pivotal clinical trials. Data from this study will be presented at the Society for Melanoma Research (SMR) Congress 2012 in Los Angeles in November. Future regulatory and clinical strategies are being reviewed in light of these results.

The CA033 study is a Celgene-sponsored, open-label, controlled, randomized study comparing ABRAXANE to standard chemotherapy, DTIC, in patients with metastatic melanoma. DTIC is the only chemotherapy approved since 1975 by the U.S. Food and Drug Administration for metastatic melanoma. In the study, 529 chemotherapy-naïve patients were randomized to receive either ABRAXANE (150mg/m2 weekly for 3 out of 4 weeks) or DTIC (1000 mg/m2 every three weeks). The primary study endpoint was independently-assessed progression free survival. Secondary endpoints included overall survival, overall response rate and disease control, safety and tolerability. 

These results are from an investigational study. ABRAXANE® is not approved for the treatment of metastatic melanoma.

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.