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Accelerated Approvals: Conversions Still Outweigh Withdrawals, But Takeda’s Exkivity Brings 2023’s Pull Count To Six

 
• By Bridget Silverman

US FDA’s Oncologic Drugs Advisory Committee will convene in November for a ‘general discussion about delayed confirmatory trials’ and the ‘continued optimization of the accelerated approval process.’

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How fast can they go in reverse? • Source: Shutterstock

Takeda Pharmaceutical Co. Ltd.’s Exkivity (mobocertinib) would be the sixth accelerated approval slated for withdrawal by the FDA in 2023 for failure to confirm clinical benefit, but the tyrosine kinase inhibitor will be one of only three AA withdrawals this year where the product is pulled from the market completely.

On 2 October 2023, Takeda said it was working with the FDA toward a voluntary withdrawal of Exkivity’s sole indication – treatment of adults with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive locally advanced or metastatic non-small cell

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