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HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Shots:

  • The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca
  • Submission was based on P-III (SACHI) study assessing the safety & efficacy of Orpathys + Tagrisso vs Pt-based doublet-CT (pemetrexed plus cisplatin or carboplatin) in this population
    Study achieved its 1EP of PFS in a planned interim analysis, as confirmed by the Independent Data
  • Monitoring Committee (IDMC). Enrollment is now complete, and results will be highlighted at future conferences

Ref: HUTCHMED | Image: HUTCHMED

Related News:- HUTCHMED’s Orpathys and Tagrisso Combination Secures the NMPA’s Breakthrough Therapy Designation for Lung Cancer

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