How to Withdraw a Drug: FDA’s Final Decision on Avastin
This article was originally published in RPM Report
Executive Summary
The “streamlined withdrawal” process for Avastin in metastatic breast cancer gave Genentech an extra 11 months to prepare for the transition to off-label status. It also gave FDA time to make preparations of its own.
You may also be interested in...
Genentech’s Cancer Product Line Expands, As Do Its Post-Market Manufacturing Obligations
Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.
J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?
Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety.
What Will CMS Do With Avastin In Breast Cancer?
With FDA’s decision to pull the indication for Avastin in breast cancer, CMS is now waiting and watching for residual use patterns.