Merck and Daiichi Sankyo voluntarily withdrew their U.S. Biologics License Application (BLA) for ifinatamab deruxtecan, an experimental therapy. The application sought accelerated approval to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum-based chemotherapy.
The companies withdrew the application after discussions with the U.S. Food and Drug Administration (FDA). The FDA concluded that data from a Phase 2 trial did not meet the requirements for accelerated approval.
Merck and Daiichi Sankyo will continue the ongoing IDeate-Lung02 Phase 3 trial and may consider a future filing based on its results.