Bristol Myers Squibb’s Inrebic Approved in Canada for Myelofibrosis
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.