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If approved by the FDA later this year, momelotinib could fulfill an area of unmet need for patients with myelofibrosis, according to an expert.
The JAK inhibitor, momelotinib, significantly improved disease-related symptoms including anemia and spleen enlargement in patients with myelofibrosis, according to recent results of the phase 3 MOMENTUM trial.
Specifically, symptom benefit was reported in significantly more patients receiving momelotinib (25%) compared with those receiving danazol (9%), a standard therapy for myelofibrosis.
Moreover, 25% of patients receiving momelotinib experienced a significant reduction in spleen size at 24 weeks. These patients also required fewer blood transfusions compared to those receiving danazol.
The drug address three main areas of symptom concern when it comes to myelofibrosis: anemia, spleen enlargement and transfusion dependency. Some JAK inhibitors that are currently approved by the Food and Drug Administration (FDA) for myelofibrosis are lacking, explained Dr. Srdan Verstovsek, lead author on the study and professor of medicine in the leukemia department the MD Anderson Cancer Center in Houston.
“The valid goal, therefore, in terms of approval of the drug but also from the perspective of value to the patients is to eliminate the need for transfusions,” he said in an interview with CURE®. “What this means is you are improving the red blood cell count. You don't need transfusions. Your quality of life is improved. And you spend less time in the hospital or doctor's office so you can engage fully again as a normal participant in society and family.”
Currently, there are three FDA approved JAK inhibitors for myelofibrosis: Jakafi (ruxolitinib), Inrebic (fedratinib) and Vonjo (pacritinib). And although they are effective in improving spleen enlargement, they can worsen anemia and cause patients to become transfusion dependent, Verstovsek explained. This can cause many patients to fail their first line of therapy but leave them with very few options for second-line therapy, which is where momelotinib would come in.
“Unfortunately, after the frontline use, (there is) not much you can do,” he said. “You can use these JAK inhibitors that are approved but they're also limited and do not really improve anemia, (which) is the primary goal. So the value of momelotinib, if it gets approved in a few months, as we expect, is that it will be positioned as the major role in a second-line setting for anemic symptomatic patients.”
The FDA previously accepted a new drug application for momelotinib, and a decision on its approval is planned to be made by June of this year.
The study included 195 patients who received treatment with either momelotinib plus placebo or danazol plus placebo. The side effects with momelotinib were similar to those previously reported in other trials including diarrhea, nausea, weakness and irritated skin.
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