Fast Track designation granted for cesalatamig in NSCLC
- Sponsor
- OncoC4 Inc.
- Drug
- cesalatamig
- Indication
- Non-small cell lung cancer (NSCLC) progressed after PD-(L)1-targeted immunotherapy and platinum-based chemotherapy
FDA granted Fast Track designation to OncoC4's cesalatamig (AI-081), an investigational PD-1/VEGF bispecific antibody, for NSCLC after prior PD-(L)1 immunotherapy and platinum chemotherapy.
What this means
Non-small cell lung cancer (NSCLC) that keeps growing after PD-(L)1-targeted immunotherapy and platinum-based chemotherapy has few effective options and a poor prognosis. Cesalatamig (development code AI-081) is an investigational antibody from OncoC4 that engages two targets at once: PD-1 on immune cells (to restore an anti-tumor immune response) and VEGF (a growth factor that tumors use to build new blood vessels). OncoC4 says its molecule binds VEGF more than 40 times more tightly than bevacizumab-based competitors in the same class. On Sept 16, 2026 the FDA granted cesalatamig Fast Track designation, which lets the sponsor communicate more frequently with the agency and become eligible for expedited-review pathways once efficacy data support a filing. The pivotal BiPAVE-001 Phase 1/2 program is enrolling in the US (NCT06635785) and China (CTR20253261), with a registrational Phase 3 planned.