BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) has received FDA approval for TEVIMBRA® (tislelizumab-jsgr) as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have undergone prior systemic chemotherapy not including a PD-(L)1 inhibitor. TEVIMBRA is set to be accessible in the U.S. by the second half of 2024.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene, expressed, “Today’s FDA approval of TEVIMBRA for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our BLA for first-line ESCC patients, represents a significant step in our commitment to bringing this therapy to more patients around the world.”
The FDA’s approval is based on the RATIONALE 302 trial, which demonstrated a significant survival benefit for TEVIMBRA compared to chemotherapy in the intention-to-treat (ITT) population. In the TEVIMBRA arm, the median overall survival (OS) was 8.6 months compared to 6.3 months in the chemotherapy arm. The safety profile of TEVIMBRA was also favorable over chemotherapy.
Syma Iqbal, M.D., Associate Professor of Clinical Medicine, Section Chief Gastrointestinal Oncology, Division of Medical Oncology and Cancer Physician in Chief, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, commented on the trial results, stating, “The RATIONALE 302 trial showed that patients with previously treated ESCC who received TEVIMBRA saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients.”
TEVIMBRA, a PD-1 inhibitor, has also received approval by the European Commission and a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) for various indications.
The FDA is currently reviewing Biologics License Applications (BLAs) for TEVIMBRA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC, as well as for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The target action dates are scheduled for July and December 2024, respectively.
TEVIMBRA has shown promise in numerous registration-enabling trials, demonstrating its potential to improve survival benefits and quality of life for cancer patients across various tumor types, both as a monotherapy and in combination with other regimens. Over 900,000 patients have been prescribed TEVIMBRA globally to date.
For more information about TEVIMBRA and its indications, including important safety information, refer to the full prescribing information.
