Merck and Daiichi Sankyo Withdraw Accelerated Approval Request for Lung Cancer ADC

Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer (ES-SCLC), citing that the FDA found their data package did not meet the necessary criteria.

The companies proposed using I-DXd, an antibody-drug conjugate, for ES-SCLC patients whose disease had progressed on or after platinum-based chemotherapy. However, the FDA indicated that the supporting data 'do not satisfy requirements needed to support an accelerated approval for the proposed indication.'

Merck and Daiichi Sankyo will continue studying I-DXd in a Phase 3 trial, which could be used as future regulatory filing material.