Merck and Daiichi Sankyo have withdrawn their request for accelerated FDA approval of ifinatamab deruxtecan, or I-DXd, for adults with extensive-stage small cell lung cancer that has worsened after platinum chemotherapy. The companies said on Sept. 25 that discussions with the FDA indicated the supporting data, including results from the Phase 2 IDeate-Lung01 trial, did not meet the requirements for accelerated approval.
The FDA has not published its reasoning, and the companies did not describe the agency's specific concerns. The agency had accepted the application and granted it priority review in April, OncLive reported.
