(Cholangiocarcinoma) Pemazyre Approved for Sale in Japan
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- August 10, 2021
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On June 1, 2021, Incyte Biosciences Japan announced the commercial launch of Pemazyre in Japan, primarily targeting patients with FGFR2-positive, unresectable cholangiocarcinoma who have progressed after chemotherapy.
This approval was based on the results of the FIGHT-202 Phase 2 clinical trial. The FIGHT-202 trial consisted of three cohorts in which patients took oral Pemazyre 13.5 mg once daily: Cohort A — patients with FGFR2 fusion genes and gene rearrangements; Cohort B — patients with other FGF/FGFR gene alterations; Cohort C — patients without FGF/FGFR gene alterations. The primary endpoint was objective response rate in Cohort A.
What is Pemazyre?
Pemazyre is an oral tyrosine kinase inhibitor with potent inhibitory activity against FGFR1/2/3. The recommended dosing regimen is once-daily oral administration of 13.5 mg for 14 consecutive days followed by 7 days off, comprising one treatment cycle.
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