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By Elias SchisgallMerck & Co. and Daiichi Sankyo have withdrawn their application seeking accelerated approval for a small cell lung cancer treatment, saying the data they had submitted to the Food and Drug Administration was insufficient.The two companies said they decided to withdraw the Biologic…
The companies said the U.S. biologics license application for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after discussions with the FDA. They said data from the phase 2 trial did not meet requirements for accelerated approval.
The companies said the U.S. biologics license application for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after discussions with the FDA. Enrollment continues in a Phase 3 trial of the drug in relapsed ES-SCLC.
The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cance…