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The CHMP recommends approval of fedratinib for the treatment of myelofibrosis

Dec 15, 2020

Fedratinib, a pyrimidine-based JAK2 and FLT3 inhibitor, has recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), supporting the European Medical Agency’s (EMA) approval for marketing authorization for treating disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (PMF), post-polycythemia vera MF, or post-essential thrombocytosis MF. Patients will be eligible if ruxolitinib has failed to achieve a response or if they have not previously received JAK inhibitors.

The positive opinion was based on the favorable results of the phase III JAKARTA and JAKARTA-2 trials, which investigated the efficacy and safety of oral doses of fedratinib given once daily in patients with intermediate-2 or high-risk primary or secondary MF.

The CHMP recommendation will be reviewed by the European Commission (EC), and a final decision is expected within two months. Its approval is particularly important for patients who have failed ruxolitinib.

The U.S. Food and Drug Administration (FDA) and Health Canada previously approved fedratinib for the treatment of adults with intermediate-2 or high-risk primary or secondary MF. Due to suspected serious neurological toxicities, fedratinib was placed on a 4-year hold by the FDA prior to its approval. Read more about fedratinib’s approval timeline here.

  1. Bristol Myers Squibb receives positive CHMP opinion for Inrebic® (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis. Published Dec 11, 2020. Accessed Dec 15, 2020.