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BeiGene's tislelizumab is approved again in China

 Last Update: 2022-05-21
 Source: Internet
 Author: User

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hpv squamous cell carcinoma

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Esophageal cancer is mostly squamous cell carcinoma or adenocarcinoma

The decision marks the eighth indication for the anti-PD-1 antibody tislelizumab in China, although it has yet to receive regulatory approval abroad

"Tislelizumab significantly improved overall survival (OS) in patients with ESCC as a second-line therapy in a Phase III trial and was well tolerated," said Mark Lanasa, senior vice president and chief medical officer of BeiGene

The approval is based on recent results from the Phase III RATIONALE 302 study, which evaluated the efficacy and safety of tislelizumab versus chemotherapy as second-line therapy in patients with locally advanced or metastatic ESCC

Trial results presented at last year's American Society of Clinical Oncology (ASCO) meeting showed that compared with chemotherapy, tislelizumab reduced the risk of death by 30 percent in ESCC patients, with median survival times of 8.

In January 2021, Novartis agreed to pay BeiGene an upfront payment of $650 million for the rights to tislelizumab in several key markets outside of China, including North America, the European Union, the United Kingdom and Japan

Original source:

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https://firstwordpharma.
com/story/5549877.
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