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Innovent’s Pemazyre (pemigatinib) Receives the NMPA’s Approval for the Treatment of Locally Advanced or Metastatic Cholangiocarcinoma

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Innovent’s Pemazyre (pemigatinib) Receives the NMPA’s Approval for the Treatment of Locally Advanced or Metastatic Cholangiocarcinoma

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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