Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously ...

Daiichi Sankyo and Merck have voluntarily withdrawn the U.S. Biologics License Application for accelerated approval of ifinatamab deruxtecan in extensive-stage small cell lung cancer patients, citing insufficient data to meet FDA requirements from the phase 2 IDeate-Lung01 trial. Enrollment continues in a phase 3 trial (IDeate-Lung02), with further phase 3 studies underway for other cancer types.

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