Genentech May Not Get A Chance To Appeal FDA's Decision To Withdraw Avastin's Breast Cancer Approval
Executive Summary
Genentech has been clear that it intends to appeal FDA's determination that the breast cancer indication for Avastin should be revoked, but the agency may not let the appeal go forward.
You may also be interested in...
Accelerated Approval: Avastin, Makena Bookend A Watershed Decade For US FDA’s Expedited Pathway
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
AMAG Open To Another Makena Trial, But Also Appears Ready To Challenge Any Withdrawal Request
CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.
FDA “Regulatory Flexibility” On Accelerated Approval Must Result In Some Withdrawals
If all drugs cleared for accelerated approval succeed in their confirmatory studies, then FDA is being overly conservative in its use of the expedited approval pathway, FDA Office of Hematology and Oncology Products Director Richard Pazdur says at the AACR annual meeting.