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‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals

Executive Summary

Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.

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Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.

PI3K Inhibitors: Overall Survival, Adverse Events And Dose Optimization Top US FDA’s Concerns

Agency will ask its Oncologic Drugs Advisory Committee whether future approvals in the class should be supported by randomized data, instead of single-arm studies, given potential overall survival detriment seen in randomized trials to date for four drugs.

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