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12:00 AM
 | 
Sep 20, 2010
 |  BioCentury  |  Regulation

Avastin Side-step

New Genentech data for FDA means 3 more months of Avastin sales in breast cancer

By submitting new information to FDA for Avastin bevacizumab for HER2-negative first-line metastatic breast cancer, Genentech Inc. bought itself and patients three months of reimbursed sales, during which time it may be able to follow Tarceva's path in turning around a doubtful outcome at FDA.

The agency, which looked likely to rescind its accelerated approval for the indication when the PDUFA deadline was reached last Friday, now will take three months to review the new data. The accelerated approval will remain intact for that time.

Nearly everyone seems to agree the drug is effective for some patients, including members of FDA's Oncologic Drugs Advisory Committee (ODAC), who voted 12-1 to remove the indication from Avastin's label in July(see BioCentury, July 26).

The problem is that the median data on progression-free survival (PFS) in confirmatory trials by Genentech and parent Roche showed that, in many women, adding Avastin to chemotherapy probably does little good. It is not yet possible to determine in advance whether or not an individual patient will benefit.

Meanwhile, the antibody is known to cause infrequent but very serious side effects, including arterial and venous thromboembolic events, congestive heart...

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