BASEL, Switzerland - The U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) from BeiGene (NASDAQ:BGNE), Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE (LON:SSE): 688235) for TEVIMBRA® (tislelizumab) in combination with chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma treatment.
The agency has set a Prescription Drug User Fee Act target action date for December 2024.
The application submission is based on data from the global Phase 3 RATIONALE-305 trial, which reported a median overall survival of 15.0 months in patients receiving TEVIMBRA plus chemotherapy compared to 12.9 months for those on placebo plus chemotherapy. This reflects a 20% reduction in the risk of death.
The study also showed a higher objective response rate and median duration of response with TEVIMBRA.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene, highlighted the urgent need for new treatments for gastric cancer, which is often diagnosed at an advanced stage. He stated that the FDA's acceptance is a step towards providing a new option for patients with typically poor prognoses.
The safety profile of TEVIMBRA in combination with chemotherapy was described as manageable and consistent with that of anti-PD-1 antibodies. However, grade ≥3 treatment-related adverse events occurred in over half of the patients treated with TEVIMBRA plus chemotherapy.
Gastric cancer is the fifth most common cancer globally and has a high mortality rate. In the U.S., the five-year survival rate is 36%. TEVIMBRA, an anti-PD-1 monoclonal antibody, is designed to aid the immune system in detecting and fighting tumors.
BeiGene has conducted over 17 potentially registration-enabling trials with TEVIMBRA, with positive outcomes from multiple Phase 3 and Phase 2 trials. The medication has been prescribed to over 900,000 patients worldwide.
The company, which aims to develop more affordable and accessible cancer treatments, has previously obtained approval from the European Commission for TEVIMBRA to treat advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. The FDA is also reviewing BLAs for TEVIMBRA for other indications with decisions expected in July 2024.
This news is based on a press release statement from BeiGene, Ltd.
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