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Summit Therapeutics announces FDA acceptance for filing of ivonescimab BLA

Summit Therapeutics (SMMT) announced that the 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 Prescription Drug User Fee Act goal action date of November 14.

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