WS Investor
14 Apr 2026, 10:08
Daiichi Sankyo and Merck & Co. announced that the U.S. Food and Drug Administration has granted Priority Review to the Biologics License Application for ifinatamab deruxtecan (I-DXd), a potential new treatment for extensive-stage small cell lung cancer (ES-SCLC).
The therapy is intended for adult patients whose disease has progressed after platinum-based chemotherapy, an area with limited treatment options. If approved, it would become a first-in-class B7-H3 directed antibody-drug conjugate.
The application is supported by results from the Phase 2 IDeate-Lung01 trial, with additional data from the Phase 1/2 IDeate-PanTumor01 study. The drug had previously received Breakthrough Therapy Designation from the FDA in August 2025.
The FDA is reviewing the application under Priority Review, as well as its Real-Time Oncology Review and Project Orbis programs, which aim to accelerate access to promising cancer treatments. A regulatory decision is expected by October 10, 2026.
Overall, the development marks a significant step toward a new treatment option for a highly aggressive cancer type, with potential to address unmet medical needs in late-stage small cell lung cancer.
The therapy is intended for adult patients whose disease has progressed after platinum-based chemotherapy, an area with limited treatment options. If approved, it would become a first-in-class B7-H3 directed antibody-drug conjugate.
The application is supported by results from the Phase 2 IDeate-Lung01 trial, with additional data from the Phase 1/2 IDeate-PanTumor01 study. The drug had previously received Breakthrough Therapy Designation from the FDA in August 2025.
The FDA is reviewing the application under Priority Review, as well as its Real-Time Oncology Review and Project Orbis programs, which aim to accelerate access to promising cancer treatments. A regulatory decision is expected by October 10, 2026.
Overall, the development marks a significant step toward a new treatment option for a highly aggressive cancer type, with potential to address unmet medical needs in late-stage small cell lung cancer.