The approval of Inrebic (fedratinib) for myelofibrosis is the first FDA-approval of a new therapy for myeloproliferative neoplasms in nearly a decade. We at the MPN Research Foundation are thrilled to see more options for people living with myelofibrosis who have long suffered from few options for relief. We hope this approval ushers in a new era with many more new safe and effective options for people living with PV, ET and MF!
INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). The endpoints focused on spleen size reduction and symptom relief. It is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Abnormal activation of JAK2 is associated with myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. According to Celgene, INREBIC does more to inhibit the JAK2-selective mutation than the other JAK family members JAK1, JAK3, and TYK2.
Fedratinib will be marketed by the name Inrebic. It has a complicated history including being put on clinical hold by the FDA after cases of Wernicke’s encephalopathy were discovered. Inrebic (Fedratinib) was resurrected by the original creator – John Hood – after hearing from patients who had been on the study who had benefited from the drug. It was taken under Celgene’s wing, who worked with FDA to understand the data previously collected before the trial was put on hold, and ensure that the drug was safe and efficacious before issuing this approval.
You can read more about the approval in Celgene’s press release. Please be sure to discuss any questions about your diagnosis or appropriate treatment options with your physician and healthcare team. We will share more information including about pricing of the drug and any financial assistance programs as details become available.