BeiGene wins FDA nod for Tevimbra in first-line esophageal cancer

 BeiGene (NASDAQ:ONC) announced Tuesday that the U.S. Food and Drug Administration (FDA) approved its anti-tumor agent Tevimbra as a first-line therapy for certain patients with esophageal cancer as part of a combination regimen.

Specifically, the anti-PD-1 therapy will therefore be indicated in the U.S. together with platinum-containing chemotherapy as a first-line treatment for adults with esophageal squamous cell carcinoma whose cancers express PD-L1 proteins. According to the FDA, patients with unresectable or metastatic forms of ESCC will be eligible for the therapy.

Previously, Tevimbra was indicated in the U.S. as a single agent for late-line treatment of adults with unresectable or metastatic ESCC.

It was also licensed by the FDA as part of a combination regimen with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers.

Tevimbra’s latest approval is backed by data from BeiGene’s (NASDAQ:ONC) RATIONALE-306, which reached the main goal, indicating a statistically significant improvement in overall survival in adults with ESCC.

https://www.msn.com/en-us/health/other/beigene-wins-fda-nod-for-tevimbra-in-first-line-esophageal-cancer/ar-AA1AdBjB