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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Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.

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.