BeiGene’s Tevimbra Wins First US Approval Following Tough Regulatory Path

2024-03-15

上市批准临床结果

Pictured: Facade of the FDA's building in Maryland/iStock, Grandbrothers The FDA on Thursday approved BeiGene’s PD-1 blocker tislelizumab—now to be marketed under the brand name Tevimbra—for the treatment of unresectable or metastatic esophageal squamous cell carcinoma. Thursday’s approval comes months after Novartis turned its back on tislelizumab, returning global rights to BeiGene. The companies signed a collaboration contract for tislelizumab in January 2021, but ran into several regulatory roadblocks. In January 2022, the FDA elected to defer its action on tislelizumab’s application in esophageal squamous cell carcinoma (ESCC) given delays in its inspection of the biotech’s facilities in China. According to BeiGene, Thursday’s regulatory victory represents Tevimbra’s first approval in the U.S. The therapy has been approved for 11 indications in China, where it is the leading PD-1 inhibitor. The company expects to launch Tevimbra in the U.S. in the second half of the year. BeiGene CMO of Solid Tumors Mark Lanasa in a statement said that with the approval, along with another pending application, “Tevimbra is poised to be a critical pillar of our solid tumor development program,” which currently includes more than 17 registration-enabling studies across various cancer indications. Per Tevimbra’s label, it can be used as a monotherapy for patients who had undergone prior systemic chemotherapy that did not include a PD-(L)1 blocker PD-(L)1 blocker. The therapy does not have a boxed warning but comes with precautions against immune-mediated adverse events, infusion-related reactions and embryo-fetal toxicity. Tevimbra is a humanized monoclonal antibody that works by targeting and binding to the PD-1 protein, blocking it from interacting with Fc-gamma receptors found on macrophages. This mechanism of action allows Tevimbra to boost the immune system’s anti-cancer action and prevents tumor cells from evading the body’s immune detection. The FDA’s approval on Thursday is backed by data from the RATIONALE 302 study, which enrolled 512 patients and evaluated Tevimbra as a second-line treatment option. Its results showed that Tevimbra led to a statistically significant improvement in overall survival versus the investigator’s choice of chemotherapy. Tevimbra was also found to be safe overall. The most common adverse events included dysregulated levels of albumin, glucose, hemoglobin and lymphocytes, as well as anemia, fatigue and weight loss. BeiGene is also proposing Tislelizumab as a first-line treatment option for unresectable, recurrent locally advanced or metastatic ESCC, and for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA is currently reviewing these applications and is expected to release its decisions in July and December 2024, respectively. Tevimbra’s regulatory win follows the FDA’s approval last week of its BTK inhibitor Brukinsa BTK inhibitor Brukinsa (zanubrutinib), combined with Genentech’s Gazyva (obinutuzumab), for the treatment of relapsed or refractory follicular lymphoma. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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