Pharma Focus Asia

BeiGene's TEVIMBRA® Granted FDA Approval for Advanced or Metastatic Esophageal Squamous Cell Carcinoma Following Prior Chemotherapy

Friday, March 15, 2024

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) has received approval from the U.S. Food and Drug Administration (FDA) for TEVIMBRA® (tislelizumab-jsgr) as a standalone treatment for adult patients diagnosed with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). This approval is specifically for patients who have undergone prior systemic chemotherapy that did not involve a PD-(L)1 inhibitor. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene, expressed enthusiasm for this milestone, highlighting TEVIMBRA's significance as the company's first immunotherapy product and its potential as a cornerstone of their solid tumor development program.

The FDA's decision was based on the positive outcomes of the RATIONALE 302 trial, where TEVIMBRA demonstrated a notable improvement in survival rates compared to chemotherapy among patients with previously treated ESCC. Dr. Syma Iqbal, Associate Professor of Clinical Medicine, emphasized the critical need for innovative treatment options in ESCC, underlining TEVIMBRA's potential to offer meaningful benefits to patients.

TEVIMBRA's approval in the U.S. follows its authorization by the European Commission for ESCC treatment after prior chemotherapy in 2023. Additionally, regulatory bodies are currently reviewing BeiGene's applications for TEVIMBRA in first-line ESCC treatment and in gastric or gastroesophageal junction adenocarcinoma.

BeiGene has initiated numerous trials to evaluate TEVIMBRA's efficacy across various tumor types, with promising results indicating its potential to improve outcomes for cancer patients globally.

RATIONALE 302 is a global Phase 3 trial comparing TEVIMBRA with chemotherapy as a second-line treatment for unresectable or metastatic ESCC, which is the predominant subtype of esophageal cancer globally.

ESCC is a significant cause of cancer-related mortality worldwide, characterized by limited treatment options and poor prognosis, particularly in advanced stages.

TEVIMBRA is an anti-PD-1 monoclonal antibody designed to enhance the immune system's ability to combat tumors while minimizing adverse effects commonly associated with traditional treatments.

TEVIMBRA is indicated for adult patients with unresectable or metastatic ESCC following prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
TEVIMBRA may lead to immune-mediated adverse reactions, which can range from mild to severe. Prompt identification and management of these reactions are essential for patient safety.
Common adverse reactions associated with TEVIMBRA include changes in laboratory parameters such as increased glucose and decreased hemoglobin, as well as fatigue, musculoskeletal pain, and respiratory issues.

This FDA approval represents a significant advancement in ESCC treatment options and underscores BeiGene's commitment to addressing unmet needs in oncology.


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