Innovent’s Pemazyre (pemigatinib) Receives the NMPA’s Approval for the Treatment of Locally Advanced or Metastatic Cholangiocarcinoma
Shots:
- The approval was based on the P-II (FIGHT-202) & P-II (bridging/CIBI375A201) study that evaluates pemigatinib in patients aged ≥18 yrs. with LA or metastatic CCA with documented FGFR2 fusion or rearrangement
- As data cut of April 2020 & Jan 2021 in the P-II (FIGHT-202) & CIBI375A201 study, 108 & 30 patients with pemigatinib (13.5mg/day) showed the IRRC-confirmed ORR (37.0% & 50%) while in (FIGHT-202) study, the therapy showed 4 CR, m-DoR (8.08) with responses lasting ≥ 6mos. in 26 of the 40 (66.0%) responding patients & ≥ 12mos. in 15 (37.5%) patients
- The safety profiles of both studies are similar & were well tolerated. The therapy has been approved in the US & EU for the same indication & in Japan for BTC
Ref: PR Newswire | Image: Innovent
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