Genentech May Not Get A Chance To Appeal FDA's Decision To Withdraw Avastin's Breast Cancer Approval
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.
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Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
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.
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.