China's NMPA approves tislelizumab for patients with second-line ESCC

Sino-American biotech firm BeiGene (Nasdaq: BGNE) has announced that the China National Medical Products Administration (NMPA) has granted approval for its anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy.

This adds to the NMPA approval in March this year for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Also approved in China for other indications, tislelizumab generated sales of $255.1 million in full-year 2021.

“As a second-line treatment for patients with ESCC, this differentiated checkpoint inhibitor demonstrated significant improvements in overall survival and was generally well-tolerated in our Phase III trial of tislelizumab,” commented Dr Mark Lanasa, senior vice president, chief medical officer, solid tumors, at BeiGene, adding: “Tislelizumab regulatory submissions in this indication submitted by Novartis are under review by the US FDA and the European Medicines Agency, highlighting our commitment to advancing its progress on behalf of the many patients around the world with ESCC and other forms of cancer.”