European Commission Approves BeiGene’s TEVIMBRA for First-Line Treatment of Advanced/Metastatic Esophageal Squamous Cell Carcinoma and Gastric or Gastroesophageal Junction Cancer

Approval Date:
The European Commission approved TEVIMBRA (tislelizumab) on November 27, 2024, for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy12.

Indications:
TEVIMBRA is approved for use in combination with platinum-based chemotherapy for ESCC and with platinum- and fluoropyrimidine-based chemotherapy for G/GEJ adenocarcinoma in patients whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%12.

Clinical Trials:
The approval was based on data from the Phase 3 RATIONALE-306 and RATIONALE-305 trials, which demonstrated a statistically significant overall survival benefit for patients treated with TEVIMBRA in combination with chemotherapy12.

Safety Data:
The safety profile was evaluated in over 2,800 patients who received TEVIMBRA as either monotherapy or in combination with chemotherapy, with the most common Grade 3 or 4 adverse reactions including neutropenia, thrombocytopenia, anemia, fatigue, and others12.

Global Impact:
TEVIMBRA is approved in 42 countries and has been used to treat more than 1.3 million patients globally, highlighting its potential across multiple tumor types and disease settings1.

Sources:

1. https://ir.beigene.com/news/european-commission-approves-beigene-s-tevimbra-for-first-line-treatment-of-advanced-metastatic-esophageal-squamous-cell-carcinoma-and/22ce8afc-1ba7-4525-82dd-058f6cfea63c/

2. https://www.onclive.com/view/ec-approves-frontline-tislelizumab-plus-chemo-for-advanced-escc-and-gastric-gej-cancer