FDA Approves Momelotinib for Myelofibrosis With Anemia

The US Meals and Drug Administration (FDA) immediately accredited the JAK inhibitor momelotinib (Ojjaara) for myelofibrosis sufferers with anemia, in response to a press release from maker GSK.

Momelotinib is the fourth JAK inhibitor to be accredited by the company for myelofibrosis however the one one indicated for sufferers with hemoglobin ranges under 10 g/dL.

It is an necessary improvement as a result of, whereas JAK inhibitors are normal therapy for myelofibrosis, these beforehand accredited for the unusual blood most cancers may cause cytopenia, notably anemia, which, satirically, can be an indicator of myelofibrosis itself.

This problem makes utilizing JAK inhibitors for myelofibrosis difficult, in response to Anthony Hunter, MD, a myeloid malignancies specialist at Emory College College of Medication, Atlanta, Georgia, who spoke on the subject just lately on the Society of Hematologic Oncology annual assembly in Houston. “Momelotinib is a vital rising agent for these extra anemic sufferers.” Momelotinib has a spleen response corresponding to ruxolitinib — the primary JAK inhibitor accredited for myelofibrosis in america — and considerably greater charges of transfusion independence, though decrease charges of symptom management, he stated.

In GSK’s press launch, hematologist/oncologist Ruben Mesa, MD, govt director of Atrium Well being Wake Forest Baptist Complete Most cancers Middle in Winston-Salem, North Carolina, stated that “with momelotinib, we have now the potential to determine a brand new normal of look after myelofibrosis sufferers with anemia.”

Momelotinib’s specific indication is for “the therapy of intermediate or high-risk myelofibrosis, together with major myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia.”

The once-daily oral treatment was accredited primarily based on two trials. One trial, MOMENTUM, confirmed statistically important response with respect to constitutional signs, splenic response, and transfusion independence in anemic sufferers handled with momelotinib versus danazol.

An anemic subset of the SIMPLIFY-1 trial confirmed comparable spleen quantity discount versus ruxolitinib however a numerically decrease symptom response price.

The most typical momelotinib adversarial reactions in trials had been thrombocytopenia, hemorrhage, bacterial an infection, fatigue, dizziness, diarrhea, and nausea.

M. Alexander Otto is a doctor assistant with a grasp’s diploma in medical science and a journalism diploma from Newhouse. He’s an award-winning medical journalist who labored for a number of main information retailers earlier than becoming a member of Medscape and can be an MIT Knight Science Journalism fellow. E-mail:  [email protected]

For extra from Medscape Oncology, be part of us on X (formerly known as Twitter) and Facebook.