FDA approves Ojjaara for myelofibrosis with anemia
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The FDA approved momelotinib for treatment of patients with myelofibrosis and anemia regardless of prior myelofibrosis therapy.
The approval applies to adults with intermediate- or high-risk myelofibrosis — including primary or secondary myelofibrosis.
Momelotinib (Ojjaara, GSK) — a selective, oral JAK1, JAK2 and ACVR1/ALK2 inhibitor — is the only therapy approved in the United States for this indication.
Approximately 40% of patients with myelofibrosis have moderate to severe anemia at the time of diagnosis. Almost all patients with myelofibrosis develop anemia during their disease course.
These patients typically require transfusions, and those who are transfusion dependent have a poor prognosis.
“With momelotinib, we have the potential to establish a new standard of care for [patients with myelofibrosis and anemia],” Ruben A. Mesa, MD, FACP, president and executive director of Atrium Health Levine Cancer Institute and Atrium Health Wake Forest Baptist Comprehensive Cancer Center, as well as a Healio | HemOnc Today Editorial Board Member, said in a GSK press release. “Addressing key manifestations of myelofibrosis — including anemia, constitutional symptoms and splenomegaly — makes a significant difference in the treatment regimen for these patients, who have limited options to address these aspects of the disease.”
The FDA based approval on data from the MOMENTUM study, as well as data from a subpopulation from the SIMPLIFY-1 trial.
MOMENTUM assessed the efficacy and safety of momelotinib vs. danazol for treatment and reduction of key manifestations of myelofibrosis among patients with myelofibrosis and anemia who had received JAK inhibitor therapy. The trial showed benefit with momelotinib with regard to constitutional symptoms, splenic response and transfusion independence.
SIMPLIFY-1 assessed the efficacy and safety of momelotinib vs. ruxolitinib (Jakafi, Incyte) for patients with myelofibrosis who had not received a JAK inhibitor.
The most common adverse events reported in these trials included thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea and nausea.
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