By Anthony O. Goriainoff

 

AstraZeneca PLC said Wednesday that China has conditionally approved Orpathys for patients with non-small cell lung cancer and mesenchymal-to-epithelial transition gene alterations.

The pharmaceutical company said that continued approval is contingent upon the successful completion of a confirmatory trial, and that it was based on positive results from a Phase 2 trial conducted in the country.

"Orpathys demonstrated robust anti-tumor activity based on an independent review of objective response rate in the trial's primary endpoint and its disease control rate," the company said.

AstraZeneca said the approval of Orpathys follows a priority review designation by China's Center for Drug Evaluation of the National Medical Products Administration, and represents the first global regulatory approval for the MET tyrosine kinase inhibitor.

 

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

 

(END) Dow Jones Newswires

June 23, 2021 02:36 ET (06:36 GMT)

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