FDA hearing on breast cancer drug set for this week

Jun 28 2011

Genentech, the maker of Avastin, will appeal to the Food and Drug Administration to make its drug available as a treatment for breast cancer — asking for one more chance to prove its efficacy.

The New York Times: Genentech To Appeal To FDA For Breast Cancer Drug
Genentech this week will step up its efforts to keep the drug Avastin available as a treatment for breast cancer, urging the Food and Drug Administration to give it one more chance to prove the medicine works. At a hearing on Tuesday and Wednesday in suburban Washington, Genentech will ask the F.D.A. to reconsider its proposal last December to revoke the approval of Avastin for breast cancer on the grounds that new studies did not confirm that the drug helped patients (Pollack, 6/26).

The Wall Street Journal: Showdown Over Use Of Cancer-Drug Avastin
An unprecedented hearing is set this week for Roche Holding AG's cancer drug Avastin, with Food and Drug Administration scientists fighting to have their decision to revoke Avastin's accelerated approval for breast cancer upheld. The decision by an FDA appeals panel, and ultimately FDA Commissioner Margaret Hamburg, is likely to affect the agency's program to allow conditional approval for potentially life-saving drugs. FDA officials describe Avastin for breast cancer as a classic case of a drug that looked promising but turned out to carry high risk with minimal benefit. They want to pull approval for breast-cancer use after provisionally granting it in 2008 (Mundy, 6/27).