By Ben Glickman
MorphoSys said its study of a treatment for myelofibrosis, a rare form of blood cancer, reached its primary endpoint, clearing the way for a new drug application in mid-2024.
The German pharmaceutical company said Monday its Phase 3 trial of pelabresib in combination with ruxolitinib in myelofibrosis patients found a statistically significant and clinically meaningful improvement in the portion of patients with a 35% or greater reduction in spleen volume after 24 weeks.
There was also a meaningful reduction in myelofibrosis symptoms, a key secondary endpoint, according to the company.
MorphoSys now intends to submit a new drug application for pelabresib in combination with ruxolitinib to U.S. and European regulators in mid-2024.
The company's combination therapy received fast track designation from the Food and Drug Administration in treating myelofibrosis in 2018.
Write to Ben Glickman at firstname.lastname@example.org
(END) Dow Jones Newswires