Genentech: Avastin Breast Cancer Drug

By Andrea: http://nursingoncologyjob.com

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),recently announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin® (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment. In accordance with FDA guidelines, the agency has extended the review period for the sBLAs by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.


At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The FDA is currently reviewing two sBLAs that Genentech submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech's effort to convert the accelerated approval to a full approval.


"We are pleased by the FDA's decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period," said Hal Barron, M.D., executive vice president, Product Development and chief medical officer.


Today's announcement does not impact Avastin's availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries. Doctors with questions about the use of Avastin for advanced breast cancer can call Genentech's Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS.


In February 2008, FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. The approval was based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. There are no data available showing that Avastin improves disease-related symptoms or survival in advanced HER2-negative breast cancer.


About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF (vascular endothelial growth factor) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.


Avastin is approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.

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