07:17 AM EDT, 05/27/2025 (MT Newswires) -- BeiGene ( ONC ) said Tuesday that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of its drug Tevimbra in combination with gemcitabine and cisplatin as a first-line treatment for adults with recurrent or metastatic nasopharyngeal cancer.

The recommendation was based on results from a 263-patient phase 3 study of Tevimbra plus chemotherapy which met its primary endpoint of extending progression-free survival (PFS) by nearly two months compared with placebo plus chemotherapy, the company said.

The median overall survival for Tevimbra plus chemotherapy was 45.3 months versus 31.8 months for chemotherapy plus placebo, the company said.

Tevimbra is already approved in Europe as a treatment for other cancers, including non-small cell lung cancer and gastric or gastroesophageal junction adenocarcinoma, the company said.

Nasopharyngeal carcinoma is a cancer of the head and neck that begins in the upper throat with an overall five-year survival rate of 63%.

Shares of BeiGene ( ONC ) were down more than 1% in recent premarket activity.