FDA Approves Inrebic to Treat Myelofibrosis

The Food and Drug Administration (FDA) approved Inrebic (fedratinib) as the first new treatment in nearly a decade for patients with myelofibrosis, according to Celgene — the agent’s manufacturer.

“Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” Dr. Ruben Mesa, director of the Mays Cancer Center at UT Health San Antonio Cancer Center MD Anderson, said in a press release. “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.”

Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells, which can lead to anemia, weakness, fatigue and enlargement of the spleen and liver, among other symptoms.

The agency approved the JAK-2 inhibitor for treatment in patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis based on findings from the JAKARTA trial.

The study demonstrated that patients experienced a 35% or great spleen volume reduction. Serious side effects included cardiac failure (5%) and anemia (2%).

Check back later for more information on what this approval means for patients.