By Mauro Orru 
 

Novartis AG said Monday that the Food and Drug Administration accepted its biologics license application for tislelizumab for people with esophageal cancer.

The Swiss pharmaceutical company said the FDA's acceptance comes after a Phase 3 trial where tislelizumab met the primary endpoint of improvement in overall survival in people with advanced or metastatic esophageal squamous cell carcinoma who had received prior systemic therapy.

"We are advancing tislelizumab as a key cornerstone of our immunotherapy program and PD-1 backbone for combination therapy. We will work with regulatory authorities to ensure it is available for people with esophageal cancer as soon as possible," said Jeff Legos, executive vice president and global head of oncology and hematology development.

 

Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94

 

(END) Dow Jones Newswires

September 13, 2021 01:29 ET (05:29 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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