FDA Approves Fedratinib (Inrebic) for Myelofibrosis

August 16, 2019

First new drug approval for the condition in nearly a decade. 

The FDA has approved Fedratinib (Inrebic, Celgene Corporation) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) Myelofibrosis. 

Fedratinib is a kinase inhibitor to be administered as 400 mg capsules taken once daily with or without food. For patients on CYP3A inhibitors or are suffering from severe renal impairment, reduced dosage regimens are listed in the full prescribing information. 

Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” said Ruben Mesa, MD, Director of the Mays Cancer Center at UT Health San Antonio Cancer Center MD Anderson in a statement. “There has not been a new treatment approved for this disease in nearly a decade. With INREBIC, physicians and patients now have another option available for myelofibrosis.”

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Fedratinib’s approval stems from the results of two phase 3, multicenter, randomized, double-blind, placebo-controlled trials (JAKARTA and JAKARTA 2). Both trials included a total of 608 patients, 459 of which had myelofibrosis. 97 of those patients were previously treated with ruxolitinib. 

Results from the JAKARTA trials included a 35% reduction of spleen volume in 37% of patients in the fedratinib arm, compared with 1% of patients in the placebo group; and a 50% reduction of Total Myelofibrosis Symptom Score, including night sweats, itching abdominal discomfort, early satiety, pain under ribs on the left side, and bone and muscle pain). 

Fedratinib includes a boxed warning of fatal encephalopathy, as well as warnings of anemia and thrombocytopenia, gastrointestinal toxicity, hepatic toxicity, and amylase and lipase elevations. 

Fatal adverse events that occurred in 1% of trial participants include a cardiogenic shock. 

Other adverse events that occurred in 21% of patients treated with fedratinib includediarrhea, nausea, anemia, and vomiting

 

 

Full Prescribing Information