The US Food and Drug Administration (FDA) has approved BeiGene’s TEVIMBRA (tislelizumab-jsgr) for the treatment of adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy.
The approval for TEVIMBRA as monotherapy comes as a significant advancement for patients who have not previously been treated with a PD-(L)1 inhibitor.
A humanised immunoglobulin G4 anti-programmed cell death protein 1 monoclonal antibody, TEVIMBRA is set to become available in the US in the second half of 2024.
The FDA’s decision is supported by results from the RATIONALE 302 trial, a global, randomised, open-label Phase III study.
It assessed the efficacy and safety of TEVIMBRA versus the investigator’s choice of chemotherapy in 512 patients across 132 research sites in 11 countries.
TEVIMBRA significantly improved median overall survival (OS) in the intention-to-treat (ITT) population compared to chemotherapy.
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Patients treated with TEVIMBRA had a median OS of 8.6 months versus 6.3 months for those receiving chemotherapy, a clinically meaningful survival benefit.
TEVIMBRA’s safety profile was found to be favourable when compared to chemotherapy.
The most common adverse reactions, which included laboratory abnormalities, were manageable and consistent with expectations for this class of drug.
TEVIMBRA also received approval from the European Commission in 2023 to treat advanced or metastatic ESCC after previous chemotherapy.
The European Medicines Agency (EMA) granted a positive opinion for TEVIMBRA for non-small cell lung cancer across three indications in February 2024.
The FDA is currently reviewing biologics licence applications for the antibody in other cancer indications, with target action dates set for July and December 2024.
These applications include the use of TEVIMBRA as a first-line treatment for unresectable, recurrent, locally advanced or metastatic ESCC and for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
BeiGene solid tumours chief medical officer Mark Lanasa stated: “The FDA approval of TEVIMBRA for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our BLA for first-line ESCC patients, represents a significant step in our commitment to bringing this therapy to more patients around the world.
“As BeiGene’s first drug candidate produced through our immuno-oncology programme and second approved medicine in the US, TEVIMBRA is poised to be a critical pillar of our solid tumour development programme, which spans more than 17 registration-enabling clinical trials in more than 30 countries across regions globally.”
This month, the FDA granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) for patients with advanced forms of follicular lymphoma.
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