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

Merck and Daiichi Sankyo have withdrawn their US application for accelerated approval of an experimental lung cancer therapy, ifinatamab deruxtecan. This decision follows discussions with the FDA, which determined that data from a mid-stage clinical study did not meet requirements for early green light. The therapy was under review to treat adults with aggressive small cell lung cancer whose disease had worsened after standard chemotherapy.

ifinatamab deruxtecan is a targeted cancer therapy, known as an antibody-drug conjugate, which works by killing tumor cells while leaving healthy ones unharmed. This marks the second pullback under the multibillion-dollar cancer alliance between Merck and Daiichi Sankyo. The companies plan to use results from a larger late-stage trial comparing ifinatamab deruxtecan with standard chemotherapy options to seek approvals.