Jakafi ruxolitinib regulatory update

Incyte said FDA updated the label of hematology drug Jakafi ruxolitinib to include recommended dosing guidance for patients with low platelet counts and additional safety information. Specifically, the new label recommends a starting dose of 5 mg twice daily for patients with baseline platelet counts of 50,000-100,000/L, with the flexibility for subsequent dose modifications based on safety and efficacy. Patients with baseline platelet counts of 100,000-200,000/L are still recommended to initiate treatment at 15 mg twice daily and at 20 mg twice daily for patients with counts >=200,000/L. The label also includes a warning that progressive multifocal leukoencephalopathy (PML) has been reported with Jakafi treatment for myelofibrosis (MF). ...