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Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Shots:

  • NMPA approved limertinib (oral EGFRm TKI) to treat LA/M EGFR T790M-mutated NSCLC in adults, based P-IIb trial assessing limertinib in (n=301) NSCLC patients
  • This study showed 68.8% ORR, 92.4% DCR, plus 11mos. mPFS with 11.1mos. mDoR. It also showed ORR & mPFS of 65.9% & 10.6mos., respectively in patients with assessable CNS lesions with favourable safety.
  • Additionally, a P-III trial assessing limertinib vs gefitinib as 1L therapy of LA/M EGFRm+ NSCLC met its 1EP, results of which will be reported at upcoming conferences or publications. Another NDA for LA/M EGFR 19DEL+ or L858R+ NSCLC is under NMPA review

Ref: Innovent & Ask Biopharma | Image: Innovent &  Ask Biopharma

Related News:-  Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

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