The NMPA has accepted the company’s sNDA of savolitinib for treatment-naïve or previously treated locally advanced or metastatic MET Exon 14 NSCLC patients
The sNDA was supported by the P-IIIb clinical evaluation to assess the safety, effectiveness & tolerability of savolitinib to treat locally advanced or metastatic NSCLC patients having MET Exon 14 mutations
The study showed an ORR of 62.1%, DCR of 92%, mDoR of 12.5mos. & mPFS of 13.7mos. with mOS not attained at a median follow-up of 20.8mos. in treatment-naïve patients while an ORR of 39.2%, DCR of 92.4%, mDoR of 11.1mos. & mPFS of 11mos. with mOS not reached at a median follow-up of 12.5mos. was seen in previously treated patients
Ref: HUTCHMED | Image: HUTCHMED
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