Summit: FDA가 EGFRm NSCLC에서 ivonescimab BLA의 PDUFA 일정을 2026년 11월 14일로 설정

FDA accepted Summit’s BLA for ivonescimab plus chemotherapy in EGFR-mutated NSCLC after prior TKI therapy and assigned a PDUFA goal date of November 14, 2026. The filing rests on the global Phase III HARMONi trial; updated OS data showing consistent HR 0.76 in both Western and Asian subgroups were provided to the agency.

핵심 사실

제출: 2026년 7월 23일 PM 08:07
이벤트: PDUFA 날짜 확정
방향: 중립
기업: SMMTSummit Therapeutics
자산: ivonescimab
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2026년 11월 14일 · 긍정적
PDUFA 일자: 2026년 11월 14일
HR OS(HARMONi): 0.76
HR OS(HARMONi-6): 0.66

출처 발췌

EX-99.1 2 a2026_prx0723xq22026earn.htm EX-99.1 a2026_prx0723xq22026earn Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2026 Consistent Overall Survival Observed in Western, Asian Patients in Updated Analysis from Phase III HARMONi Study in EGFRm NSCLC Post-TKI Setting for Ivonescimab Plus Chemotherapy vs. Chemotherapy Ivonescimab Plus Chemotherapy Achieves Statistically Significant and Clinically Meaningful Overall Survival Benefit in 1L Squamous NSCLC HARMONi-6 Trial Conducted in China, the First Phase III Head-to-Head Clinical Study to Demonstrate Superiority over an Anti-PD-(L)1 Antibody-Containing Regimen HARMONi-3 Global Phase III 1L NSCLC Study: Squamous Cohort Final PFS Analysis Events Expected to Be Reac

SEC 8-K