NICE Recommends GSK's Omjjara as treatment option for myelofibrosis patients with anaemia
22 Feb 2024
Drug ApprovalAccelerated Approval
It can also be used as a treatment for symptoms in adult myelofibrosis patients with moderate to severe anaemia.
Myelofibrosis, a rare blood cancer characterized by bone marrow scarring, affects approximately 1,970 individuals across England, Wales, and Northern Ireland.
Momelotinib marks the first JAK-inhibitorJAK-inhibitor treatment available in England and Wales for both newly diagnosed and previously treated adult myelofibrosis patients with moderate to severe anaemia. GSK plc welcomed the decision by NICE to issue Final Draft Guidance (FDG) recommending Omjjara.
The FDG recommends momelotinib for myelofibrosis patients with moderate to severe anaemia who have not received a JAK-inhibitorJAK-inhibitor or ruxolitinib, subject to specific criteria. This recommendation signifies a significant step forward, making momelotinib the inaugural JAK-inhibitorJAK-inhibitor treatment accessible on the NHS in England and Wales for adult myelofibrosis patients with moderate to severe anaemia.
Dr. Donal McLornan, Consultant in Haematology and Stem Cell Transplantation at University College London Hospital, expressed optimism about the approval, emphasizing its potential to provide treatment flexibility and improved care for affected patients.
He 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.”
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Myelofibrosis often results in splenomegaly, constitutional symptoms like fatigue and bone pain, as well as severe anaemia and thrombocytopenia. Given the debilitating nature of the disease, supportive care such as red blood cell transfusions become crucial for patients.
In response to the NICE recommendation, GSK is actively collaborating with health authorities to ensure patient access across England, Wales, and Northern Ireland.
Efforts are also underway to facilitate access in Scotland pending appraisal by the Scottish Medicines Consortium.
The recommendation from NICE follows the recent granting of a Great Britain Marketing Authorization (GB MA) for momelotinib by the Medicines and Healthcare products Regulatory Agency (MHRA). This authorization was based on robust data from clinical trials evaluating momelotinib's safety and efficacy, including MOMENTUM and SIMPLIFY-1 studies.
Momelotinib's indication covers the treatment of splenomegaly or symptoms in adult patients with moderate to severe anaemia associated with various forms of myelofibrosis. The overall safety profile, as demonstrated in clinical trials, underscores its potential as a viable treatment option.
Myelofibrosis poses significant challenges to patients and healthcare providers alike. GSK remains dedicated to advancing transformative medicines in oncology, including haematologic malignancies, to address unmet medical needs and improve patient outcomes.
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