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On August 26, Incyte announced that the FDA has approved the marketing of the FGFR inhibitor Pemazyre (pemigatinib, pemitinib) for the treatment of adult patients
Pemetinib in the FIGHT-203 study showed a persistent and high CR rate and CCyR rate: in patients in the chronic phase with or without EMD (N=18), the CR rate was 78% (14/18; 95% CI 52, 94)
。 In patients with or without EMD in the blast phase (N=4), two patients achieved CR
.
In patients with only EMD (N=3), one patient achieved CR
.
For all patients (N = 28), the complete cytogenetic response (CCyR) was 79% (22/28; 95% CI: 59, 92)
。
Pemetinib has been approved in the United States, the European Union, Japan, and China for the treatment of previously treated adult patients
with FGFR2 fusion or other rearrangements of unresectable, locally advanced, or metastatic cholangiocarcinoma.
Cinda owns the clinical development and commercialization rights
of the product in Chinese mainland and in Hong Kong, Macau and Taiwan.