Hutchmed (China) (HCM) said late Wednesday that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for the combination of Orpathys and Tagrisso for the treatment of patients with a specific type of non-small cell lung cancer.
The company said this acceptance also triggers a milestone payment from AstraZeneca (AZN), which is leading the development of Orpathys outside China.
The decision was supported by data from a late-stage trial that evaluated the efficacy and safety of a combination of the two drugs in comparison to chemotherapy and met its primary endpoint of progression-free survival in an interim analysis.
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