Merck, Daiichi Sankyo withdraw U.S. application for ifinatamab deruxtecan lung cancer therapy

  • Merck and Daiichi Sankyo voluntarily withdrew the U.S. application for ifinatamab deruxtecan.
  • FDA found mid-stage study data insufficient to support accelerated approval.
  • The therapy targeted adults with extensive-stage small cell lung cancer after chemotherapy failure.

Merck and Daiichi Sankyo have voluntarily withdrawn their U.S. application seeking accelerated approval for ifinatamab deruxtecan, an experimental therapy for adults with extensive-stage small cell lung cancer whose disease worsened after standard chemotherapy. The decision followed discussions with the U.S. Food and Drug Administration, which determined that data from a mid-stage clinical study did not satisfy the requirements for an early approval. The application had covered certain previously treated patients, and the development was identified as MRK stock news.

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