FDA Approves a New Indication for Avastin

Genentech’s cancer drug Avastin won approval to treat platinum-resistant, recurrent ovarian cancer in combination with chemotherapy, marking the eighth time the FDA has approved an indication on the blockbuster product.

The latest approval for Avastin (bevacizumab) was based on a Phase III trial that compared progression-free survival between patients given Avastin and chemotherapy vs. chemotherapy alone. Patients in the Avastin arm experienced 6.8 months of median progression-free survival, 3.4 months more than patients given only chemotherapy.

Ovarian cancer causes more deaths than any other gynecological cancer in the U.S., Genentech says. Up to this point, the only available treatments were the chemotherapy regimens with which the company compared Avastin.

The drug has been approved for lung cancer, kidney cancer, colorectal cancer, brain cancer and cervical cancer. It is part of the recent wave of targeted cancer therapies, binding to the vascular endothelial growth factor protein that helps tumors obtain blood supply. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.