BeiGene Provides Update on FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers
BeiGene, Ltd. - American Depositary Shares (BGNE)
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Source: Business Wire
Vote recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors in advanced esophageal squamous cell carcinoma and gastric/gastroesophageal junction cancersBiologics License Applications for TEVIMBRA in these indications are under review with the FDA SAN MATEO, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA® (tislelizumab-jsgr), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (1%) and gastric/gastroesophageal junction (G/GEJ) cancers expressing PD-L1 1%.The committee reviewed efficacy and safety data from the Phase 3 RATIONALE-305 (G/GEJ) and RATIONALE-306 (ESCC) studies, as well as other pivotal studies from the two other PD-
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BGNE
Earnings
- 8/7/24 - Beat
BGNE
Sec Filings
- 9/27/24 - Form 144
- 9/26/24 - Form 8-K
- 9/19/24 - Form 4
- BGNE's page on the SEC website