Esophageal Squamous Cell Carcinoma (ESCC)

BeiGene Announces U.S. FDA Acceptance of Biologics License Application for Tislelizumab in Esophageal Squamous Cell Carcinoma

Retrieved on: 
Monday, September 13, 2021
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States, said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Key Points: 
  • This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States, said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.
  • Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there.
  • We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world.
  • The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Esophageal Squamous Cell Carcinoma (ESCC)

Retrieved on: 
Thursday, July 8, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Clinical medicine, Gastrointestinal cancer, Medicine, Cancer, Esophageal cancer, ESCC, Squamous cell carcinoma, Breakthrough therapy, Pembrolizumab, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China.

Key Points: 
  • We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China.
  • We look forward to further communication with CDE and hope this medicine will benefit Chinese patients with locally advanced or metastatic ESCC soon.
  • In China, more than 95% of patients are esophageal squamous cell carcinomaii.
  • https://gco.iarc.fr/today/explore
    ii Guidelines for diagnosis and treatment of esophageal cancer in 2018, Health Commission of the people's Republic of China.

BeiGene Announces Positive Topline Results for Global Phase 3 Trial of Tislelizumab in Esophageal Squamous Cell Carcinoma

Retrieved on: 
Wednesday, January 27, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Medicine, Cancer treatments, Health, Chemotherapy, Occupational safety and health, Oncology, BeiGene, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, Tislelizumab Clinical Program, BeiGene

In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population, when compared to chemotherapy.

Key Points: 
  • In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population, when compared to chemotherapy.
  • The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified.
  • We are excited to announce the improved overall survival observed in another Phase 3 trial for tislelizumab when compared to chemotherapy standard of care.
  • BeiGene plans to discuss the RATIONALE 302 data with health authorities globally and present data at an upcoming medical conference.