Daiichi Sankyo and Merck Withdraw BLA for Ifinatamab Deruxtecan

The Biologics License Application (BLA) for ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody drug conjugate, has been voluntarily withdrawn by Daiichi Sankyo and Merck from the U.S. FDA.

The application was seeking accelerated approval in the U.S. for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy.

The decision to withdraw the BLA is based on discussions between Daiichi Sankyo and Merck with the FDA, which determined that data from the IDeate-Lung01 phase 2 trial does not meet requirements for accelerated approval.