BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been granted approval by the US Food and Drug Administration (FDA) as part of a first-line combination treatment for advanced gastric cancer.
The drug has been authorised for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1.
Gastric cancer is the fifth most common cancer globally, with an estimated 27,000 patients diagnosed with the disease in the US alone in 2024.
BeiGene’s Tevimbra, which is designed to help the body’s immune cells detect and fight tumours, is already approved in the US as a monotherapy for adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
The FDA’s latest decision on the therapy was supported by positive results from the late-stage RATIONALE-305 trial, in which Tevimbra in combination with investigator’s choice of chemotherapy resulted in a 20% reduction in the risk of death compared to placebo plus chemotherapy in patients with advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma cancer.
Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “This is the second US approval for Tevimbra [in 2024], underscoring its potential to address critical needs in oncology.”
The decision comes just one month after Tevimbra was approved by the European Commission, also for use alongside platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment for adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
At the same time, the EU regulator approved the drug in combination with platinum-based chemotherapy to treat adults with unresectable, locally advanced or metastatic ESCC in the first line.
An additional application is under review with the FDA for Tevimbra as a first-line treatment for adults with locally advanced unresectable or metastatic ESCC.
“We remain deeply grateful to the patients, clinicians and researchers whose commitment and courage have made this progress possible – and we look forward to building on this momentum in 2025,” Lanasa said in the most recent announcement.