BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March this year, marking the first indication in the U.S. for TEVIMBRA .
Tislelizumab is a PD-1 inhibitor that has demonstrated significant improvements in overall survival and progression-free survival in a Phase III trial compared to standard chemotherapy. BeiGene’s North America General Manager, Matt Shaulis, stated that the company has priced TEVIMBRA 10% lower than other PD-1 therapies approved for the same indication, aiming to enhance patient access to this treatment.
The approval was based on data from the RATIONALE 302 trial, which met its primary endpoint in the intent-to-treat (ITT) population. In this study, the median overall survival (OS) was 8.6 months for the TEVIMBRA group, compared to 6.3 months for the chemotherapy group (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of Tislelizumab was found to be superior to that of chemotherapy.
Common adverse reactions associated with Tislelizumab include increased blood glucose, decreased hemoglobin, lymphocyte reduction, sodium decrease, albumin decrease, alkaline phosphatase increase, anemia, fatigue, elevated aspartate aminotransferase, musculoskeletal pain, weight loss, elevated alanine aminotransferase, and cough.
TEVIMBRA is now part of a competitive landscape in the U.S. that includes Merck’s Keytruda and Bristol-Myers Squibb’s (BMS, NYSE: BMY) Opdivo, both of which are also approved for second-line esophageal cancer. According to Fierce Pharma, BeiGene estimates the average wholesale acquisition cost of Tislelizumab to be $15,075 per month.
Additionally, the FDA is currently reviewing Tislelizumab for first-line treatment of locally advanced unresectable and metastatic ESCC and gastric/gastroesophageal junction (G/GEJ) cancer.- Fineline.com
