Ifinatamab deruxtecan application for previously treated extensive-stage small cell lung cancer withdrawn
MRK•Merck and Daiichi Sankyo voluntarily withdrew the U.S. biologics license application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after FDA discussions; Phase 2 data did not satisfy approval requirements.
1. Application withdrawn
Merck and Daiichi Sankyo voluntarily withdrew the U.S. biologics license application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer. The companies said the withdrawal followed FDA discussions because Phase 2 data did not satisfy approval requirements.
2. Trials continue
Patient enrollment continues in the IDEATE-Lung02 Phase 3 trial. Two additional Phase 3 trials of ifinatamab deruxtecan are underway in castration-resistant prostate cancer and esophageal squamous cell carcinoma.
