GSK’s momelotinib has been recommended for approval by the European Medicines Agency’s human medicines committee as the first treatment option specifically indicated for myelofibrosis patients with moderate-to-severe anaemia.

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

Eligible patients will also have either not been treated with JAK inhibitors before or have been treated with Novartis’ Jakavi (ruxolitinib), GSK said.

Myelofibrosis is a rare blood cancer that can lead to severely low blood counts, with about 40% of patients having moderate-to-severe anaemia at the time of diagnosis and nearly all patients developing anaemia at some point in the course of their disease.

Transfusions are often required by myelofibrosis patients with anaemia and more than 30% will discontinue treatment due to anaemia.

Momelotinib, which would be available in the EU under the trade name Omjjara, is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease.

The CHMP’s positive opinion of the drug is supported by results from the pivotal MOMENTUM study, which evaluated momelotinib versus another anaemia treatment called danazol in an anaemic, symptomatic and JAK inhibitor-experienced myelofibrosis population.

The trial met all of its primary and key secondary endpoints, with momelotinib-treated patients showing improved symptoms, spleen size and transfusion independent compared with patients receiving danazol.

Data from a subpopulation of adult patients with moderate-to-severe anaemia from the late-stage SIMPLIFY-1 trial assessing the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy also supported the company’s application.

Nina Mojas, senior vice president, oncology global product strategy, GSK, said: “Momelotinib has a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with moderate-to-severe anaemia… This positive CHMP opinion is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer.”

The recommendation will now be reviewed by the European Commission, with a decision from the regulator expected by early 2024.

https://www.pmlive.com/pharma_news/gsks_momelotinib_recommended_by_chmp_to_treat_myelofibrosis_patients_with_anaemia_1503782