FDA Approves BeiGene's First Drug Candidate Produced Through Its Immuno-Oncology Program For Esophageal Cancer

On Thursday, the FDA approved BeiGene Ltd’s BGNE approved Tevimbra (tislelizumab-jsgr) as monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. 

Tevimbra will be available in the U.S. in the second half of 2024. The approval represents the first indication in the U.S. for Tevimbra.

In September 2023, BeiGene said it would regain rights to develop, manufacture, and commercialize Tevimbra (tislelizumab), its cancer drug, from Novartis AG NVS. Under the agreement signed in 2021, the companies were jointly developing tislelizumab.

The approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy. 

In the ITT population, the median overall survival (OS) in the Tevimbra arm was 8.6 months compared to 6.3 months in the chemotherapy arm.

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Tislelizumab received approval from the European Commission for advanced or metastatic ESCC after prior chemotherapy in 2023 and a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in February 2024 as a treatment for non-small cell lung cancer across three indications.

The FDA is also reviewing Biologics License Applications for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. 

The target action dates are July and December 2024, respectively.

Last week, the FDA granted accelerated approval to BeiGene Ltd’s BGNE Brukinsa (zanubrutinib) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with Roche Holdings AG’s RHHBY Gazyva (obinutuzumab), after two or more lines of systemic therapy. 

Price Action: BGNE shares are up 0.26% at $169.34 on the last check Friday.