US FDA approves BeiGene's esophageal cancer therapy

The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

(Reuters) -The U.S. Food and Drug Administration said it has approved BeiGene's drug to treat a type of advanced esophageal cancer in patients who have previously received chemotherapy.

The therapy, branded as Tevimbra, was approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma.

Tevimbra will be available to U.S. patients in the second half of 2024, a company spokesperson said, adding that it will share pricing details closer to the launch.

The American Cancer Society estimates there will be more than 22,000 new esophageal cancer cases in the U.S. in 2024.

Tevimbra is an anti-PD-1 monoclonal antibody, a similar class of treatments as Merck's blockbuster drug Keytruda, which helps the body's immune system detect and attack tumors.

Last year, Beigene regained full global rights to Tevimbra after terminating a 2021 deal with Swiss drugmaker Novartis to jointly develop the therapy.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar and Krishna Chandra Eluri)