Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC
Shots:
- The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026)
- BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who have progressed after treatment with a 3rd generation EGFR TKI
- Ivonescimab (SMT112/ AK112) is a bispecific antibody that combines PD-1 immune checkpoint blockade with VEGF-mediated anti-angiogenesis in a single molecule
Ref: Summit | Image: Summit | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com


