Latest news on molotinib/mometinib

Momelotinib/momelotinib has a different mechanism of action and has inhibitory capabilities along three key signaling pathways: Janus kinase (JAK) 1, JAK2, and type I activin A receptor (ACVR1). Inhibition of JAK1 and JAK2 improves systemic symptoms and splenomegaly. Furthermore, inhibition of ACVR1 results in reduced circulating hepcidin levels, which may contribute to anemia-related benefits.

In September 2023, the U.S. Food and Drug Administration (FDA) approved molotinib, brand name Ojjaara, for the treatment of moderate or high-risk myelofibrosis (MF) in adults with anemia, including primary myelofibrosis or secondary myelofibrosis (after polycythemia vera [PV] and after essential thrombocythemia [ET]).

In January 2024, the European Commission approved the marketing of Omjjara for the treatment of disease-related splenomegaly (spleen enlargement or symptoms, andJanus kinase) in adult patients with moderate to severe anemia and primary myelofibrosis, postpolycythemia vera myelofibrosis, or postessential thrombocythemia myelofibrosis. Omjjara is also approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of symptoms of myelofibrosis in adults who are moderate or severe anemia.

Molotinib is a once-daily oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. Molotinib was approved in June 2024 for patients with newly diagnosed or previously treated myelofibrosis, based on data from the pivotal Phase 3 MOMENTUM trial and the SIMPLIFY-1 trial.