N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

24 Nov 2022

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Makena-reflections — • Source: Shutterstock

The dispute between US FDA’s Center for Drug Evaluation and Research and Covis Pharma over the preterm birth prevention drug Makena marked the second-ever public hearing under the agency’s accelerated approval withdrawal regulations, coming more than 11 years after the proceeding involving the breast cancer indication for Genentech, Inc. ’s Avastin (bevacizumab).

The two hearings featured sponsors, drugs and circumstances that were very different.