Incyte's Pemazyre Wins European Approval For Bile Duct Cancer

The European Commission (EC) has approved Incyte Corporation's INCY Pemazyre (pemigatinib) for the treatment of cholangiocarcinoma, rare cancer that forms in the bile duct.
The approval covers adults' treatment with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
The decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in January recommending the conditional marketing authorization of Pemazyre.
The decision is based on data from the FIGHT-202 study. Pemazyre monotherapy resulted in an overall response rate of 37% (primary endpoint) and a median duration of response of eight months (secondary endpoint).
Pemazyre was generally well tolerated.
Warnings and precautions for Pemazyre include high and low phosphate levels in the blood, vision or eye problems, blood creatinine increase, a risk of harm to the fetus in pregnant women.
Price Action: INCY shares are lower by 0.1% at $81.69 in market trading hours on the last check Monday.