FDA

Tevimbra now approved for gastric/GEJ cancers

January 8, 2025

Brand name: Tevimbra

Generic name: tislelizumab-jsgr

Manufacturer: BeiGene

Approval date: December 27, 2024

FDA approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).

Tevimbra was previously approved in the U.S. as monotherapy for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that didn’t include a PD-(L)1 inhibitor.

Efficacy

Approval of the new indication was based on results from the phase 3 RATIONALE-305 trial (NCT03777657) which included 997 patients with HER2-negative previously untreated unresectable or metastatic G/GEJ. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with Tevimbra plus chemotherapy vs. 12.9 months for patients treated with placebo plus chemotherapy (HR: 0.80; 95% CI, 0.70, 0.92; P = 0.0011), resulting in a 20% reduction in the risk of death.

Safety

The most common Grade 3 or 4 adverse reactions when Tevimbra was given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, ALT increased, AST increased, diarrhea, pneumonitis, and hepatitis.

Recommended dose

The recommended dosage of Tevimbra is 200 mg as an IV infusion q3wks. Administer the first infusion over 60 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.

Sources:

BeiGene. (2024, December 27). Tevimbra approved in US for first-line treatment of gastric and gastroesophageal junction cancers in combination with chemotherapy. [Press release]. https://hkexir.beigene.com/news/tevimbra-approved-in-u-s-for-first-line-treatment-of-gastric-and-gastroesophageal-junction-cancers-in-combination/cedb475b-fcfe-47a4-8afe-8a501d9cf849/

BeiGene: Tevimbra (tislelizumab-jsgr). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761417s000lbl.pdf