FDAnews
www.fdanews.com/articles/199157-bristol-myers-squibbs-inrebic-approved-in-canada-for-myelofibrosis

Bristol Myers Squibb’s Inrebic Approved in Canada for Myelofibrosis

September 22, 2020

Health Canada has approved Bristol Myers Squibb’s Inrebic (fedratinib) for the treatment of certain patients with enlarged spleen caused by myelofibrosis, a rare bone marrow cancer.

The agency specifically approved the drug for patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

The approval was based on results of two clinical trials in which Inrebic demonstrated a clinically meaningful reduction in spleen volume for patients with myelofibrosis.

The FDA approved Inrebic for myelofibrosis patients in August 2019.

View today's stories