SciFocus/Dec 29, 2024 — In a significant advancement for cancer treatment, the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) in combination with chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults with PD-L1 expression. This marks the second FDA approval for TEVIMBRA in 2024, highlighting its potential to address critical needs in oncology.
“FDA approval of TEVIMBRA for gastric and gastroesophageal junction cancers is a major milestone in mission to deliver transformative therapies to patients with cancer.”
Key Highlights
- Approval Based on Phase 3 Trial: The approval is supported by the RATIONALE-305 trial, which showed TEVIMBRA plus chemotherapy significantly improved overall survival (OS) compared to placebo plus chemotherapy.
- Survival Benefit: Patients treated with TEVIMBRA had a median OS of 15.0 months, a 20% reduction in the risk of death compared to 12.9 months for the placebo group.
- Safety Profile: Common Grade 3 or 4 adverse reactions included neutropenia, thrombocytopenia, anemia, and fatigue.
- Second FDA Approval in 2024: TEVIMBRA was previously approved for esophageal squamous cell carcinoma (ESCC) and is under review for additional indications.
- Global Impact: TEVIMBRA is approved in over 42 countries, with more than 1.3 million patients treated globally.
Why This Matters
Gastric cancer is the fifth most common cancer worldwide, with nearly 1 million new cases diagnosed in 2022. TEVIMBRA offers a new hope for patients with advanced G/GEJ cancers, providing a clinically meaningful survival benefit and improving treatment outcomes.
Future Directions
BeiGene, soon to be renamed BeOne Medicines Ltd., continues to expand TEVIMBRA’s clinical development program, with ongoing trials across 34 countries and regions.
The FDA’s approval of TEVIMBRA for gastric and gastroesophageal junction cancers underscores its potential as a transformative therapy. This milestone reaffirms BeiGene’s commitment to advancing innovative treatments for patients worldwide.
