Benzinga | Mar 29, 2021 02:35PM EDT

Incyte's Pemazyre Wins European Approval For Bile Duct Cancer

* The European Commission (EC) has approved Incyte Corporation's (NASDAQ: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.