GSK gains positive CHMP opinion for momelotinib for myelofibrosis treatment
GSK has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive recommendation to the company’s momelotinib for patients with myelofibrosis.
The drug has gained this positive opinion for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis, or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
This opinion follows data from the pivotal MOMENTUM study and the phase 3 SIMPLIFY-1 trial. The MOMENTUM trial assessed the safety and efficacy of momelotinib compared to danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population, whereas SIMPLIFY-1 was intended to evaluate the efficacy and safety of the drug compared to ruxolitinib in myelofibrosis patients who had not previously been treated with a JAK-inhibitor therapy.
The most common adverse events in these trials included diarrhoea, thrombocytopaenia, nausea, headache, dizziness, fatigue, asthenia, abdominal pain and cough.
Nina Mojas, senior vice president, Oncology Global Product Strategy at GSK, commented: “Momelotinib has a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with moderate to severe anaemia. The vast majority of myelofibrosis patients will develop anaemia, causing them to require transfusions and leading a notable proportion to discontinue treatment. This positive CHMP opinion is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer.”
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