Zdrowie i gospodarka · 11/05/2011

FDA to Hold Hearing on Genentech's Proposal to Withdraw Approval for Avastin in Breast Cancer Indication

The FDA is holding a hearing to discuss Genentech's proposal to withdraw approval of bevacizumab (Avastin) for breast cancer, following a request by the company to re-evaluate the drug's accelerated approval. The hearing will focus on the regulatory standard for FDA to withdraw approval of the metastatic breast cancer indication for Avastin.