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FDA Approves Fedratinib for Myelofibrosis

Gina Columbus @ginacolumbusonc
Published: Friday, Aug 16, 2019

The FDA has approved fedratinib (Inrebic) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1

The approval is based on findings from the phase III JAKARTA2 study, which evaluated fedratinib in patients with primary or secondary myelofibrosis; results demonstrated a significant reduction in splenomegaly and symptom burden in patients with myelofibrosis. Safety data were also examined from the phase II JAKARTA-2 trial3, which evaluated the agent in patients with myelofibrosis who were previously exposed to ruxolitinib (Jakafi).

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

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