HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC
Shots:
- The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval
- Approval was based on P-IIIb study, with preliminary data from the first line cohort highlighted at WCLC 2023 & final results presented at ELCC 2024
- ORR was 62.1%, 92% DCR, 12.5mos. mDoR, 13.7mos. mPFS, mOS not attained with median follow-up of 20.8mos. in treatment-naive patients, whereas previously treated patients showed 39.2% ORR, 92.4% DCR, 11.1mos. mDoR, 11mos. mPFS & immature mOS with 12.5mos. median follow-up. Time to response was 1.4-1.6mos. in all of them
Ref: HUTCHMED | Image: HUTCHMED
Related News:- HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification
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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.
