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Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto

Executive Summary

Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.

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Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous’ withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced.

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OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

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