Merck and Daiichi Sankyo Withdraw US Application for Experimental Lung Cancer Therapy

Merck and Daiichi Sankyo have withdrawn their US application for an experimental lung cancer therapy called ifinatamab deruxtecan. The decision comes after discussions with the US Food and Drug Administration, which determined that data from a mid-stage clinical study did not meet requirements to support accelerated approval.

The companies were seeking approval to treat adults with extensive-stage small cell lung cancer whose disease had worsened after standard chemotherapy.

Although the therapy has shown promise in treating this aggressive condition, it did not meet the necessary standards for early green light from the FDA.