GSK has received approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Omjjara (momelotinib) to treat patients with myelofibrosis.
Omjjara is now authorised for usage on both newly diagnosed and previously treated myelofibrosis patients.
It is a once-a-day, oral inhibitor of Janus kinase (JAK) 1/JAK2 and activin A receptor type 1 (ACVR1) signalling pathways.
GSK gained the MHLW approval based on the results from the MOMENTUM and SIMPLIFY-I Phase 3 trials.
MOMENTUM assessed the safety and effectiveness of momelotinib compared to danazol in reducing key symptoms of myelofibrosis in anaemic, symptomatic patients who had previous treatment with a licensed JAK inhibitor.
The trial met all its primary and key secondary endpoints, showing statistically significant responses for key hallmarks of the disease.
SIMPLIFY-1, on the other hand, evaluated momelotinib against ruxolitinib in myelofibrosis patients who had not been treated with a JAK inhibitor before. The study met its primary endpoint by proving non-inferiority of momelotinib to ruxolitinib in spleen volume response and significant improvements in transfusion independence rates.
GSK oncology global product strategy senior vice president Nina Mojas said: “Myelofibrosis has a heavy disease burden, with symptomatic patients experiencing spleen enlargement, fatigue, night sweats and bone pain, along with anaemia which can lead to treatment discontinuation and dependence on regular blood transfusions.
“With the approval of Omjjara, myelofibrosis patients in Japan will have a new treatment option for this complex blood cancer.”
The Japanese approval is momelotinib’s fourth major regulatory approval for treating myelofibrosis. This follows approvals in the US, the European Union, and the UK.
In September 2023, the US Food and Drug Administration approved momelotinib under the brand name Ojjaara to treat intermediate or high-risk myelofibrosis in adults with anaemia.
In January 2024, the European Commission granted marketing authorisation for Omjjara and in the same month, the drug was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
In a separate development, the European Medicines Agency (EMA) accepted GSK’s application to expand the use of Jemperli (dostarlimab).
The British drugmaker is seeking to use Jemperli in combination with standard-of-care chemotherapy for primary advanced or recurrent endometrial cancer.
