Merck & Co. and Daiichi Sankyo have announced the voluntary withdrawal of the Biologics License Application (BLA) approval for ifinatamab deruxtecan in the United States. The decision was made following discussions with the U.S. Food and Drug Administration (FDA).
The drug, ifinatamab deruxtecan, is intended for the treatment of small cell lung cancer. The companies stated that the withdrawal is a result of ongoing dialogue with regulators regarding the application.
The news was reported by Benzinga on September 25, 2026.
