FDA Approves Beigene's Tevimbra for Esophageal Cancer

Beigene, Ltd. has just received FDA approval for Tevimbra® (tislelizumab-jsgr) as a monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. This marks a significant step for the company, as it represents the first indication in the U.S. for Tevimbra. The approval is based on the results from the global, phase 3 RATIONALE 302 trial, which showed a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy in the intention-to-treat (ITT) population.

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. The safety profile of Tevimbra was found to be favorable over chemotherapy, with the most common adverse reactions for Tevimbra including increased glucose, decreased hemoglobin, decreased lymphocytes, and decreased sodium, among others.

Furthermore, Beigene has also launched more than 17 potentially registration-enabling trials with Tevimbra, of which 11 phase 3 randomized trials and four phase 2 trials have already had positive readouts. This demonstrates Tevimbra's potential to deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types, both as monotherapy and in combination with other regimens. Additionally, more than 900,000 patients have been prescribed Tevimbra globally to date.

The FDA approval of Tevimbra is a significant development in Beigene's commitment to bringing this therapy to more patients around the world. It also represents a critical pillar of the company's solid tumor development program, which spans more than 17 registration-enabling clinical trials in more than 30 countries across regions globally. The approval of Tevimbra underscores its potential as an important treatment option for patients diagnosed with advanced or metastasized ESCC, and it highlights Beigene's dedication to addressing the unmet needs of cancer patients.

If you want to know more, read the company's complete 8-K report here.

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