Overview
Shares of Summit Therapeutics Inc. (NASDAQ:SMMT) gained 7% in early trading Thursday after the U.S. Food and Drug Administration confirmed it had accepted the company’s Biologics License Application for ivonescimab administered alongside chemotherapy in a defined lung cancer population.
Regulatory timeline and scope of the submission
The BLA seeks approval for ivonescimab in combination with chemotherapy for patients who have epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and who previously received tyrosine kinase inhibitor therapy. The FDA has set a PDUFA - Prescription Drug User Fee Act - goal action date of November 14, 2026.
Clinical evidence supporting the filing
The application is grounded in data from the Phase III HARMONi trial. That study compared ivonescimab plus platinum-doublet chemotherapy to a placebo plus chemotherapy in patients who had previously been treated with a third-generation EGFR tyrosine kinase inhibitor. Summit has characterized the treatment as addressing a substantial unmet need, estimating that more than 14,000 patients in the United States could be eligible for this regimen each year in the specified setting.
Drug profile
Ivonescimab - referred to as SMT112 in Summit’s licensed territories - is described as a novel bispecific antibody. It is engineered to combine PD-1 blockade with anti-angiogenesis activity through VEGF inhibition within a single molecule. The company highlights the drug’s tetravalent architecture, which was designed with the goal of improving upon established efficacy thresholds and safety profiles of agents that target these biological pathways.
FDA review process details
The FDA indicated it will undertake a full review of the BLA in line with Good Review Management Principles and Practices. The agency plans to hold a mid-cycle meeting and a wrap-up meeting, and to propose labeling prior to the PDUFA date, provided that no major deficiencies are identified during its review.
Patient exposure data
According to information from Akeso, the developer of the drug, more than 4,000 patients have received ivonescimab in clinical studies around the world, and about 60,000 patients have been treated with the drug commercially in China.
Market reaction
Investors reacted to the FDA’s acceptance of the filing with a share-price uptick for Summit Therapeutics early Thursday, reflecting market attention to the regulatory milestone and the path toward a potential approval decision on the stated PDUFA timeline.
Sections
- Summary: FDA acceptance of Summit’s BLA for ivonescimab in EGFR-mutated non-squamous NSCLC; PDUFA date Nov. 14, 2026; stock rose 7%.
- Clinical basis: Phase III HARMONi comparing ivonescimab plus platinum-doublet chemotherapy versus placebo plus chemotherapy in patients previously treated with a third-generation EGFR TKI.
- Exposure: >4,000 patients in clinical studies and ~60,000 treated commercially in China per Akeso.