INCY - Incyte's Pemazyre OK'd in Japan for bile duct cancer

The Japanese Ministry of Health, Labour and Welfare ((MHLW)) has approved Incyte's (INCY) Pemazyre, a selective fibroblast growth factor receptor ((FGFR)) inhibitor, for the treatment of patients with unresectable biliary tract cancer ((BTC)) with FGFR2 fusion gene, worsening after cancer chemotherapy. The approval is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. Previously, the MHLW granted Orphan Drug Designation for Pemazyre. Additionally, the EMA's Committee for Medicinal Products for Human Use has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

For further details see:

Incyte's Pemazyre OK'd in Japan for bile duct cancer