BeiGene Gets Positive CHMP Opinion for Tislelizumab to Treat Serious Esophageal Cancer
July 21 2023 - 8:33AM
Dow Jones News
By Chris Wack
BeiGene said Friday that the Committee for Medicinal Products
for Human Use of the European Medicines Agency has issued a
positive opinion recommending approval for tislelizumab to treat
adults with unresectable, locally advanced or metastatic esophageal
squamous cell carcinoma.
The biotechnology company said the marketing authorization
application for esophageal squamous cell carcinoma is based on
results from its Phase 3 study of tislelizumab's efficacy and
safety.
The study enrolled 513 patients in 11 countries in Asia, Europe
and North America. The study met its primary endpoint with a
statistically significant and clinically meaningful survival
benefit for tislelizumab compared with chemotherapy.
Tislelizumab isn't currently authorized for use in Europe.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 21, 2023 08:18 ET (12:18 GMT)
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