Merck, Daiichi Sankyo Withdraw Lung Cancer Therapy Application
Pharmaceutical giants Merck and Daiichi Sankyo have withdrawn their US application for accelerated approval of an experimental lung cancer therapy, ifinatamab deruxtecan. The decision was made after discussions with the US Food and Drug Administration (FDA), which determined that data from a mid-stage clinical study did not meet requirements to support early approval.
The companies' application aimed to treat adults with extensive-stage small cell lung cancer whose disease had worsened after standard chemotherapy. This aggressive condition is known for its poor prognosis, making the potential therapy's withdrawal significant news in the medical community.