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Withdrawal is based on FDA discussions; the companies said phase 2 data do not satisfy approval requirements. Enrollment continues in the IDEATE-LUNG02 phase 3 trial, and two additional phase 3 trials are underway.
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application for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after discussions with the FDA.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application for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after discussions with the FDA.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…