Genentech Recaps Bid to Keep Avastin’s MBC Indication

Genentech has highlighted three key reasons why the FDA should maintain Avastin’s metastatic breast cancer (MBC) indication, saying a withdrawal is contrary to the accelerated approval standards, the science on the biologic and the public health. The points were made in an argument summary released May 13 in preparation for the late June appeals hearing on the FDA’s plan to withdraw Avastin’s (bevacizumab) MBC indication.
Washington Drug Letter