Merck and Daiichi Sankyo Withdraw Lung Cancer Treatment Application

Merck and Daiichi Sankyo have withdrawn their application for accelerated approval of ifinatamab deruxtecan, a treatment for lung cancer.

The decision follows conversations with the US FDA, which stated that the current data does not meet the requirements for accelerated approval.

The drug showed promising results in clinical trials, with an objective response rate of 48.2% and a median duration of response of 5.3 months.

Despite this, the companies have decided to continue evaluating ifinatamab deruxtecan in ongoing phase 3 trials targeting advanced prostate and esophageal cancers.