Merck and Daiichi withdraw lung cancer drug filing after FDA pushback

Merck and Daiichi Sankyo voluntarily withdrew their application for accelerated approval of I-DXd in extensive-stage small cell lung cancer after the FDA said the data did not meet the requirements for approval.

The application was based on the phase 2 IDeate-Lung01 study, which enrolled 187 participants with extensive-stage small cell lung cancer who had previously received at least one line of platinum-based chemotherapy. The filing sought approval for patients whose cancer progressed on or after platinum-based chemotherapy.

Merck said enrollment in the phase 3 IDeate-Lung02 trial is nearing completion, and the partners may return to the FDA with an expanded dataset. I-DXd is also being tested in phase 3 trials in prostate cancer and esophageal squamous cell carcinoma.