Daiichi Sankyo and Merck Withdraw Small Cell Lung Cancer Treatment Application

Daiichi Sankyo and Merck have withdrawn their application for ifinatamab deruxtecan, a treatment for extensive-stage small cell lung cancer, from the US FDA due to insufficient data. The companies had sought accelerated approval based on results from the IDeate-Lung01 Phase 2 trial.

However, after discussions with the FDA, it became clear that the application would not meet requirements for accelerated approval. This decision does not impact ongoing enrollment in the IDeate-Lung02 Phase 3 trial, which is expected to be completed soon.

The companies are conducting two additional Phase 3 trials with ifinatamab deruxtecan in advanced or metastatic disease, including one for castration-resistant prostate cancer and another for esophageal squamous cell carcinoma.