FDA approval sought for frontline Tevimbra (tislelizumab) in locally advanced or metastatic esophageal squamous cell carcinoma – BeiGene

The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The application is supported by findings from the phase III RATIONALE 306 (NCT03783442) in which the addition of tislelizumab to chemotherapy (n = 326) resulted in improved overall survival (OS) vs placebo plus chemotherapy (n = 323), at a median of 17.2 months (95% CI, 15.8-20.1) vs 10.6 months (95% CI, 9.3-12.1), respectively (stratified HR, 0.66; 95% CI, 0.54-0.80; P < .0001). The 12-month OS rates in the investigative and control arms were 65.0% (95% CI, 59.4%-70.0%) and 44.9% (95% CI, 39.2%-50.3%), respectively; the 18-month rates were 48.6% (95% CI, 42.9%-54.0%) and 34.5% (95% CI, 29.2%-39.8%), respectively.

Under the Prescription Drug User Fee Act, the regulatory agency has assigned a target action date in the second half of 2024.