Ifinatamab deruxtecan (I-DXd)
Previously treated extensive-stage small cell lung cancer · Adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy
MRK · Merck
Regulatory designations
Full timeline
5 milestonesFDA decision expected
FDA assigned an October 10, 2026 PDUFA target action date to the I-DXd BLA.
Merck — BLA acceptance and PDUFA date↗FDA accepted the BLA with Priority Review
FDA accepted the application based on the Phase 2 IDeate-Lung01 and Phase 1/2 IDeate-PanTumor01 trials and placed it in the Real-Time Oncology Review and Project Orbis programs.
Merck — BLA acceptance and Priority Review↗Pivotal IDeate-Lung01 results were presented
The Phase 2 trial showed a confirmed objective response rate of 48.2% and a median response duration of 5.3 months in previously treated ES-SCLC.
Merck — IDeate-Lung01 results at WCLC 2025↗FDA granted Breakthrough Therapy designation
FDA granted Breakthrough Therapy designation for the same previously treated ES-SCLC population covered by the BLA.
Merck — I-DXd regulatory designations and IDeate-Lung01 results↗Related News
No related news available.