By Denny Jacob
BeiGene said U.S. regulators had approved its Tevimbra to treat a form of stomach cancer.
The oncology company said the Food and Drug Administration approved Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment for advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
"This is the second U.S. approval for Tevimbra this year, underscoring its potential to address critical needs in oncology," Chief Medical Officer Mark Lanasa said.
BeiGene said the approval was based on results from a global Phase 3 trial that evaluated the efficacy and safety of Tevimbra in combination with chemotherapy as a first-line treatment for adults with the disease. The company added the study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival benefit.
Tevimbra is also approved in the U.S. as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that doesn't include a PD-(L)1 inhibitor.
BeiGene added that it intends to change its name to BeOne Medicines.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
December 27, 2024 06:29 ET (11:29 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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