Avastin’s Breast Cancer Approval Followed CDER Rift On Efficacy
The Center for Drug Evaluation and Research is expected to present a united front supporting withdrawal of Avastin’s (bevacizumab) metastatic breast cancer claim at a June 28-29 hearing.
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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.
Pertuzumab’s approval came almost a year after FDA and Genentech battled over the future of bevacizumab’s breast cancer claim at an unprecedented public hearing. While both oncologic agents were approved on the basis of a median progression-free survival benefit exceeding five months, the regulatory similarities end there.
The Oncologic Drugs Advisory Committee’s July 24 meeting to discuss the merits of independent radiological review of progression assessments in a pre-specified subgroup of patients, instead of 100% of all assessments, comes three years after the agency signaled it was open to considering such an approach.