Summit Therapeutics announces US FDA acceptance of biologics license application seeking approval for ivonescimab in combination with chemotherapy in treatment of patients with EGFRm NSCLC post-TKI therapy

Summit Therapeutics

29 January 2026 - Summit Therapeutics today announced that the US FDA has accepted for filing Summit's biologics license application seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor mutated locally advanced or metastatic non-squamous non-small cell lung cancer post-tyrosine kinase inhibitor therapy. 

The FDA provided a PDUFA goal action date of 14 November 2026.

Read Summit Therapeutics press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Registration