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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