Phase 2 trial data did not meet requirements for accelerated approval in the US
Merck & Co. and Daiichi Sankyo have voluntarily withdrawn their Biologics License Application in the United States for ifinatamab deruxtecan. The application sought accelerated approval to treat adult patients with extensive-stage small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
The companies made the decision after discussions with the US Food and Drug Administration. The regulator indicated that data supporting the filing, including results from the 187-patient IDeate-Lung01 phase 2 trial, do not meet the requirements needed for accelerated approval in this indication.
Patient enrollment continues in the global IDeate-Lung02 phase 3 trial, which compares ifinatamab deruxtecan against chemotherapy choices including amrubicin, lurbinectedin or topotecan. The antibody drug conjugate is also being evaluated in two other phase 3 trials: IDeate-Prostate01 for prostate cancer and IDeate-Esophageal01 for esophageal cancer.
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