FDA Approves Momelotinib for Myelofibrosis With Anemia

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

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

It is an essential improvement as a result of, whereas JAK inhibitors are commonplace therapy for myelofibrosis, these beforehand authorised for the unusual blood most cancers could cause cytopenia, notably anemia, which, mockingly, can be a trademark of myelofibrosis itself.

This subject makes utilizing JAK inhibitors for myelofibrosis difficult, in line with 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 crucial rising agent for these extra anemic sufferers.” Momelotinib has a spleen response similar to ruxolitinib — the primary JAK inhibitor authorised for myelofibrosis in america — and considerably increased charges of transfusion independence, though decrease charges of symptom management, he mentioned.

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

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

The once-daily oral medicine was authorised primarily based on two trials. One trial, MOMENTUM, confirmed statistically vital 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 fee.

The most typical momelotinib antagonistic 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. Electronic mail:  [email protected]

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