The US Food and Drug Administration (FDA) has approved BeiGene’s Tevimbra (tislelizumab-jsgr) along with platinum-containing chemotherapy as first-line treatment for adults with unresectable or metastatic oesophageal squamous cell carcinoma.
The treatment is intended for individuals whose tumours express programmed cell death ligand 1 (PD-L1).
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Tevimbra’s latest approval stems from the outcomes of the placebo-controlled, global Phase III RATIONALE-306 study, which assessed the therapy in 649 adult subjects.
The trial showed a significant improvement in overall survival when Tevimbra was used alongside chemotherapy, against the placebo group. The safety profile of the combo was also assessed in this trial.
BeiGene Solid Tumors chief medical officer Mark Lanasa stated: “Today’s approval, our third from the FDA in less than a year, reflects our dedication to advancing innovative therapies and addressing critical needs in cancer care.
“FDA approval of Tevimbra for the first-line treatment of advanced oesophageal squamous cell carcinoma marks a significant step forward in tackling the unmet needs in this challenging disease area. We are grateful to the patients, clinicians and researchers whose commitment and courage have made this progress possible.”
Tevimbra is a humanised immunoglobulin G 4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody.
It gained approval as a single agent for treating adults with unresectable or metastatic oesophageal squamous cell carcinoma following previous systemic chemotherapy which excluded PD-L1 inhibitor, as well as in conjunction with chemo as the first-line treatment of patients with gastric and gastroesophageal junction cancers.
The antibody is engineered to decrease the interaction with Fc-gamma receptors on macrophages. It has received approval in 42 nations.
BeiGene ecently expressed its plan to rebrand as BeOne Medicines.
In September 2023, BeiGene regained Tevimbra’s worldwide rights through an agreement with Novartis.
