GSK’s Omjjara (momelotinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for myelofibrosis-related splenomegaly or symptoms in adults with moderate-to-severe anaemia.
The agency’s final draft guidance applies to both newly diagnosed and previously treated patients, although those eligible will need to have either not been treated with JAK inhibitors before or been treated with Novartis’ Jakavi (ruxolitinib).
Estimated to affect more than 1,900 people in England, Wales and Northern Ireland, myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells.
About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis and nearly all patients develop anaemia at some point over the course of their disease.
Omjjara is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease.
NICE’s recommendation comes shortly after the Medicines and Healthcare products Regulatory Agency granted marketing authorisation to the therapy. This was supported by positive results from the late-stage MOMENTUM study, which evaluated Omjjara versus another anaemia treatment called danazol in an anaemic, symptomatic and JAK inhibitor-experienced myelofibrosis population.
Data from a subpopulation of adult patients with moderate-to-severe anaemia from the phase 3 SIMPLIFY-1 trial assessing the efficacy and safety of Omjjara versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy also supported the company’s application.
“The approval of [Omjjara] offers treatment flexibility for splenomegaly or disease-related constitutional symptoms in adult myelofibrosis patients with moderate to severe anaemia,” said Dr Donal McLornan, consultant in haematology and stem cell transplantation, University College London Hospital.
“For responding patients on [Omjjara], this represents a new avenue of care where previous specific therapeutic options were limited in [Omjjara] patients with moderate-to-severe anaemia,” McLornan added.
Following the NICE recommendation, GSK said it is “working with relevant health authorities to provide access for patients across England, Wales and Northern Ireland” and “making efforts to ensure that patients in Scotland will have access to [Omjjara] by submitting evidence to the Scottish Medicines Consortium, which is currently pending appraisal”.