- FDA accepted the BLA for ifinatamab deruxtecan and granted Priority Review, with a PDUFA date of Oct 10, 2026; the application is also being reviewed under RTOR and Project Orbis.
- Ifinatamab deruxtecan is a B7-H3-directed DXd ADC carrying topoisomerase I inhibitor (exatecan-derivative) payloads.
- BLA is supported by IDeate-Lung01 Phase 2 (n=187), with dose expansion at 12 mg/kg IV every three weeks and primary endpoint of BICR-assessed ORR.
- The drug has FDA Breakthrough Therapy and multiple Orphan Drug designations and is included in global Phase 3 trials such as IDeate-Lung02.
Regulatory status
The FDA accepted the BLA for ifinatamab deruxtecan and granted Priority Review with a PDUFA date of October 10, 2026; the application is also under Real‑Time Oncology Review (RTOR) and Project Orbis, and the drug received Breakthrough Therapy designation in August 2025.
Clinical evidence
The BLA is supported by the IDeate‑Lung01 Phase 2 primary analysis (presented at WCLC 2025 and published in the Journal of Clinical Oncology) and by data from IDeate‑PanTumor01 Phase 1/2; IDeate‑Lung01 enrolled 187 patients across Asia, Europe and North America and allowed patients with asymptomatic brain metastases.
Trial design and dosing
IDeate‑Lung01 randomized patients in a dose‑optimization phase (8 vs 12 mg/kg IV every three weeks) followed by a dose‑expansion cohort at 12 mg/kg every three weeks; the primary endpoint was BICR‑assessed objective response rate per RECIST v1.1, with secondary endpoints including DOR, PFS and OS and intracranial ORR as an exploratory analysis.
Drug profile
Ifinatamab deruxtecan is an investigational B7‑H3‑directed DXd antibody‑drug conjugate composed of a humanized anti‑B7‑H3 IgG1 linked via tetrapeptide cleavable linkers to topoisomerase I inhibitor payloads (an exatecan derivative); no B7‑H3‑directed therapies are currently approved.
Development program
The global clinical program includes multiple indications and planned Phase 3 trials in SCLC (IDeate‑Lung02), castration‑resistant prostate cancer (IDeate‑Prostate01) and esophageal squamous cell carcinoma (IDeate‑Esophageal01); the drug has multiple orphan drug designations.
