Biotechnology company Genentech Inc (DNA), a member of Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK), Friday said that the U.S. Food and Drug Administration has extended the review period for the supplemental Biologics License Applications or sBLAs for Avastin by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.
Genentech said that information it submitted to the Food and Drug Administration or FDA during the review of the sBLAs for Avastin or bevacizumab for previously untreated advanced HER2-negative breast cancer has been deemed a major amendment.
The company noted that it now anticipates FDA action on the sBLAs by December 17, 2010.
Avastin is a solution for intravenous infusion and according to the company is the first FDA approved therapy designed to inhibit angiogenesis, a process by which new blood vessels develop and carry vital nutrients to a tumor.
The drug occupies the top slot among the 20 products from Roche's portfolio. In the first half of 2010, global sales of Avastin rose 14% at 3.393 billion swiss francs.
Currently, Avastin is approved for first-and second-line treatment of metastatic colorectal cancer or mCRC in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, metastatic, non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.
Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The approval was based on an improvement in progression-free survival.
According to the company, the FDA is now reviewing two sBLAs that the company submitted last year for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON 1 studies. Data from theses studies were submitted to convert the accelerated approval to a full approval.
But the drug has showed serious and sometimes fatal side effects. The company noted that, in clinical trials, some people treated with Avastin experienced Gastrointestinal perforation, severe bleeding, and surgery and wound healing problems.
The trials also revealed common adverse effects that included nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, and rectal bleeding, among others.
Across all trials, treatment with Avastin was permanently stopped in 8.4% to 21% of people because of theses side effects.
According to the Centers for Disease Controls and Prevention, breast cancer is the most common cancer among American women. A data from the National Cancer Institute revealed that, in 2010, there were 207,090 new cases of breast cancer in the U.S., with nearly 40,000 fatalities.
DNA closed Friday's regular trade at $80.43 on the NYSE.
RHHBY.PK, which is traded over the counter, closed at $34.00, down $0.11 or 0.32%.
For comments and feedback: editorial@rttnews.com