Ifinatamab Deruxtecan receives U.S. Priority Review for previously treated extensive-stage SCLC progressing after platinum-based chemotherapy

CAR-T Digest - August 2020

Weekly Digest - April 2026

13 April 2026: Ifinatamab Deruxtecan receives U.S. Priority Review for previously treated extensive-stage SCLC progressing after platinum-based chemotherapy

Daiichi Sankyo and Merck have received U.S. FDA acceptance and Priority Review for the biologics license application of ifinatamab deruxtecan for the treatment of adult patients with extensive-stage small cell lung cancer who have progressed on or after platinum-based chemotherapy
The application is supported by results from the Phase 2 IDeate-Lung01 trial, with additional evidence from the Phase 1/2 IDeate-PanTumor01 study, demonstrating clinically meaningful antitumor activity in previously treated patients
Extensive-stage small cell lung cancer remains a highly aggressive disease with limited treatment options after progression on standard therapies, underscoring the importance of new therapeutic approaches such as B7-H3–targeted ADCs
This regulatory milestone positions ifinatamab deruxtecan as a potential first-in-class B7-H3–directed DXd ADC, highlighting its novel mechanism and potential to address a high unmet need in this aggressive cancer setting
With Priority Review, Real-Time Oncology Review, and Project Orbis pathways in place, ifinatamab deruxtecan could potentially reach patients more rapidly and may play a significant role in reshaping the treatment landscape for relapsed extensive-stage small cell lung cancer if approved