FDA Panel Recommends Withdrawing Bevacizumab as BC Treatment

[Janette]

FDA Panel Recommends Withdrawing Bevacizumab as Breast Cancer Treatment

By Lianne Dane

WASHINGTON, DC -- July 20, 2010 -- A US Food and Drug Administration (FDA) advisory panel voted 12-1 to recommend to the agency that bevacizumab's (Avastin) marketing authorisation as a treatment for breast cancer be removed.

Earlier in the day, the panel voted 13-0 that a post-approval study of the drug failed to prove that the risks and adverse effect profile associated with use of bevacizumab in combination with docetaxel did not outweigh its benefits in this patient cohort.

The FDA approval of bevacizumab as a treatment for breast cancer was based on the E2100 clinical trial, which demonstrated that bevacizumab plus paclitaxel slowed the spread of breast cancer by an additional 5.5 months, compared with paclitaxel alone.

However, data from the AVADO clinical trial, which was completed post-approval, suggest that a high dose of bevacizumab used in combination with docetaxel extended progression-free survival by only 0.9 months, compared with docetaxel alone. Progression free survival was extended by only 0.8 months in patients receiving a lower dose of bevacizumab.

A second post-approval trial, RIBBON 1, demonstrated that bevacizumab combined with taxane or anthracycline-based chemotherapies extended progression-free survival by 1.2 months compared with chemotherapy alone.


SOURCE: FirstWord