Merck and Daiichi Sankyo Withdraw Lung Cancer Therapy Application

Merck and Daiichi Sankyo have withdrawn their US application for accelerated approval of ifinatamab deruxtecan, a lung cancer therapy developed under their multibillion-dollar partnership. The decision follows discussions with the FDA, which determined that data from a mid-stage clinical study did not meet requirements for an early green light.

The companies are evaluating ifinatamab deruxtecan in larger, late-stage trials comparing it to standard chemotherapy options. Patient enrollment is nearly complete for these studies, and the results will be used to seek approvals from the FDA and other global health regulators.

This is the second withdrawal of a US application under their partnership, which is worth up to $22 billion. The companies have three 'guided missile' therapies in development: ifinatamab deruxtecan, patritumab deruxtecan, and raludotatug deruxtecan.