Merck and Daiichi Sankyo voluntarily withdrew their U.S. application for ifinatamab deruxtecan (I-DXd), an experimental antibody-drug conjugate for adults with previously treated extensive-stage small-cell lung cancer (ES-SCLC).
The companies said discussions with the FDA indicated that data—including results from the Phase 2 IDeate-Lung01 trial—did not meet the requirements for accelerated approval. The filing had been seeking an early approval for patients whose cancer progressed during or after platinum-based chemotherapy.
The setback affects a drug in the companies’ 2023 cancer collaboration, which included $4 billion upfront and could be worth up to $22 billion overall. It is the second partnered drug to encounter a U.S. application withdrawal, adding regulatory uncertainty to the deal.
Development is continuing:
the companies are enrolling patients in the Phase 3 IDeate-Lung02 trial. A later filing may depend on results from that study.
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