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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
