(Cholangiocarcinoma) Pemazyre Approved for Sale in Japan

• August 10, 2021
• Read time: 1 minute

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.

Source: https://www.incyte.jp/Portals/0/adam/IncyteJPNews/UY9maNsF1k2pzZYGQrxHNQ/NewsFile/20210601_%E3%83%97%E3%83%AC%E3%82%B9%E3%83%AA%E3%83%AA%E3%83%BC%E3%82%B9%20%E6%9C%80%E7%B5%82%E7%89%88.pdf

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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