FDA to decide on Avastin before next week

SAN FRANCISCO The Food and Drug Administration will decide by Saturday whether or not Genentech’s cancer drug Avastin will be approved to fight breast cancer as well, according to the Wall Street Journal.

Members of an agency advisory committee voted 5-4 against approval in December. While the FDA isn’t required to follow the panel’s recommendations, it usually does. While it does not seem likely an approval will occur based on the committee’s vote, new reports have stated that two members of the FDA advisory panel have changed their mind to approving the drug, although the FDA has not and will not comment on these reports.

Genentech is looking for approval based on a study it submitted to the FDA that found that using Avastin in combination with Taxol, a breast-cancer drug made by Bristol-Myers Squibb, delayed the growth of patients’ tumors for 11.3 months, 5.5 months longer than Taxol alone. However, despite this, the women on Avastin in the study didn’t live significantly longer than those on Taxol, and they experienced more bad side effects, such as high blood pressure, blood clots and bowel perforation. Six deaths were linked to Avastin’s toxicity, and none to Taxol’s.

A major issue for the FDA advisers was whether slowing cancer for an extra 5.5 months is a benefit that merits market approval. Maha Hussain, an oncologist at the University of Michigan and the chairwoman of the FDA’s Oncology Drugs Advisory Committee, voted that such data don’t clear the bar. But her fellow panel member, Duke University oncologist Gary Lyman, says a 5.5-month halt in tumor growth is the best response he has seen in patients with metastatic breast cancer. “That translates – during whatever time they have left – into better quality of life,” he says.

Genentech is hoping for the approval in order to lift sales of the drug. It had sales of $2.3 billon last year, but the new approval could add an extra $2 billion a year for the company.

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