Summit Therapeutics shared a post on LinkedIn:
“Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) Seeking Approval for Ivonescimab in Combination with Chemotherapy in Treatment of Patients with EGFRm NSCLC Post-TKI Therapy
BLA Filing Based on HARMONi Global Phase III Study Results
PDUFA Goal Action Date of November 14, 2026
Significant Unmet Need Remains; Over 14,000 U.S. Patients Eligible for Treatment Each Year in This Setting
*Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).”
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