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NICE has issued guidance for GSK’s Omjjara (momelotinib) as a treatment option for disease-related splenomegaly or symptoms in adult myelofibrosis patients with moderate to severe anaemia

February 15, 2024 – Clinical Trials – GSK, NICE, fibrosis

Myelofibrosis is a rare blood cancer that can result in the progressive scarring of bone marrow (fibrosis), impairing its normal function
There are approximately 1,970 people living with myelofibrosis across England, Wales and Northern Ireland
Momelotinib is the first JAK-inhibitor treatment to be made available in England and Wales for both newly diagnosed and previously treated adult myelofibrosis patients with moderate to severe anaemia.

15 February 2024 — Middlesex, UK — GSK today welcomed a decision by the National Institute for Health and Care Excellence (NICE) to issue a Final Draft Guidance (FDG) recommending the use of Omjjara (momelotinib) as an option for treating myelofibrosis-related splenomegaly or symptoms in adults with moderate to severe anaemia who have not had a JAK-inhibitor or had ruxolitinib, only if: they have intermediate-2 or high-risk myelofibrosis, and the company provides momelotinib according to the commercial arrangement. This positive recommendation makes momelotinib the first JAK-inhibitor treatment to be made available on the NHS in England and Wales for adult myelofibrosis patients with moderate to severe anaemia, who are newly diagnosed, as well as those previously treated with ruxolitinib.

Myelofibrosis is a rare type of blood marrow cancer that disrupts the body’s normal production of blood cells. Approximately 400 people in the UK are diagnosed with myelofibrosis each year, including an estimated 370 in England, Wales and Northern Ireland. At present, there are approximately 1,970 people living with myelofibrosis across England, Wales and Northern Ireland.

Dr Donal McLornan, consultant in Haematology and Stem Cell Transplantation, University College London
Hospital, UK, said: “The approval of momelotinib offers treatment flexibility for splenomegaly or disease-related constitutional symptoms in adult myelofibrosis patients with moderate to severe anaemia. For responding patients on momelotinib, this represents a new avenue of care where previous specific therapeutic options were limited in myelofibrosis patients with moderate to severe anaemia.”

Myelofibrosis can lead to splenomegaly (enlargement of the spleen), constitutional symptoms, such as fatigue, night sweats and bone pain, as well as severely low blood counts, including anaemia (deficiency of red blood cells) and thrombocytopenia (deficiency of platelets). Nearly all people living with myelofibrosis are estimated to develop anaemia over the course of the disease. Myelofibrosis patients with anaemia may require additional supportive care, including red blood cell (RBC) transfusions.

Following the NICE recommendation, GSK is working with relevant health authorities to provide access for patients across England, Wales and Northern Ireland. GSK is also making efforts to ensure that patients in Scotland will have access to momelotinib by submitting evidence to the Scottish Medicines Consortium, which is currently pending appraisal.

This NICE guidance follows two weeks after the granting of a Great Britain Marketing Authorisation (GB MA) for momelotinib by the Medicines and Healthcare products Regulatory Agency (MHRA). This MA for momelotinib was based on data from the MOMENTUM study (phase III trial) and a subpopulation of adult patients with moderate to severe anaemia (haemoglobin <10 g/dL) from the SIMPLIFY-1 phase 3 trial. The MOMENTUM trial was designed to evaluate the safety profile and efficacy of momelotinib versus danazol for the key manifestations of myelofibrosis (such as splenomegaly, constitutional symptoms and RBC tranfusions) in an anaemic, symptomatic, JAK inhibitor-experienced population. The SIMPLIFY-1 trial was designed to evaluate the efficacy and safety profile of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK inhibitor therapy.

Momelotinib indication

Omjjara is indicated for the treatment of 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 and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Overall safety profile

The safety profile and tolerability of momelotinib was evaluated in three randomised, active-controlled clinical trials in adult myelofibrosis (n=448; MOMENTUM, SIMPLIFY-1, and SIMPLIFY-2). The most common adverse reactions were diarrhoea (23%), thrombocytopenia (21%), nausea (17%), headache (13%), dizziness (13%), fatigue (12%), asthenia (11%), abdominal pain (11%) and cough (10%); the most common severe adverse reaction (≥ Grade 3) was thrombocytopenia (11%).

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