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# Summit BLA for Lung Cancer Therapy
- URL: https://www.fdaweb.com/summit-bla-for-lung-cancer-therapy/
- Published: 2026-01-29T12:00:00.000Z
- Updated: 2026-09-14T15:31:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160572

FDA has accepted for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy. The agency has set a user fee review action target date of 11/14.

The submission is based on data from the Phase 3 HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who were previously treated with a 3rd generation EGFR TKI.

Ivonescimab is described as a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. “By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF,” the company says.