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FDA Extends Deadline for Avastin Review


September 21, 2010.

The FDA has extended the review period of the supplemental Biologics License Applications (sBLAs) for the use Roche and Genentech's Avastin - the world's top selling cancer drug - for previously untreated advanced HER2-negative breast cancer by an additional 90 days.

FDA gave fast-track approval to Avastin (in combination with chemotherapy) for treatment of some breast cancers in 2008; the drug is also is approved to treat colon, lung, brain and kidney cancers. But in July this year, an FDA advisory panel voted that approval of Avastin for breast cancer should be rescinded, stating that studies did not prove the drug would greatly benefit women with the disease and that serious side effects could occur.


FDA action on the sBLAs is now anticipated by December 17, 2010, and Genentech have issued contact numbers for doctors and patients with questions about the use of Avastin for advanced breast cancer. The FDA announcement does not impact the drug's availability for its approved uses for other cancer types in the US, or approved uses, including breast cancer, in other countries.


Hal Barron, Genentech's Vice President, Product Development and Chief Medical Officer, commented: "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."