JAK inhibitor for rare blood cancer approved in Great Britain

Stamp of approval

GSK’s Omjjara (momelotinib) has been granted marketing authorisation in Great Britain 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.

It is approved in patients who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Julian Beach, The Medicines and Healthcare products Regulatory Agency (MHRA) Interim Executive Director, Healthcare Quality and Access, said: “Myelofibrosis patients often rely on blood transfusions to counter their anaemia, but studies have shown that these transfusions are often linked to reduced quality of life and survival. Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.”

Myelofibrosis is a rare type of blood marrow cancer that disrupts the body’s normal production of blood cells. Every year, approximately 380 people are diagnosed with myelofibrosis in the UK.

Jack Harris, Vice-President UK Oncology, GSK, said: “As the first JAK-inhibitor treatment licensed in Great Britain specifically indicated for adult myelofibrosis patients with moderate to severe anaemia, this milestone could have an impact on this patient population living with myelofibrosis across Great Britain.”

The approval was supported by data from the MOMENTUM Phase III trial and a subpopulation of adult patients with moderate to severe anaemia (haemoglobin <10g/dL) from the SIMPLIFY-1 Phase III trial.

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