OMJJARA (momelotinib) - Splenomegaly and symptoms related myelofibrosis

The clinical benefit of OMJJARA (momelotinib), 100 mg, 150 mg and 200 mg film-coated tablets is moderate only in 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 and who have been treated with ruxolitinib.

Considering:

• the lack of evidence of superiority in terms of spleen volume response rate versus best available therapy;
• the lack of evidence of superiority in terms of transfusion independence versus danazol;
• the questionable choice of danazol as a comparator in the MOMEMTUM study, making it difficult to interpret the results obtained in this study;

and despite:

• evidence of the superiority of OMJJARA (momelotinib) compared to danazol on the proportion of patients with at least 50% reduction in total symptom score as measured by the MFSAF, with 24.62% of patients in the momelotinib group versus 9.23% of patients in the danazol group, i.e. a difference between the two groups of 15.67% (95% CI [5.54; 25.81], p=0.0095);
• evidence of the non-inferiority of OMJJARA (momelotinib) compared to danazol on the transfusion independence rate (co-primary endpoint) enabling the results of the hierarchical secondary endpoints to be taken into account;
• a similar safety profile to the other representatives of the JAK inhibitors class;

the Committee considers that OMJJARA (momelotinib), 100 mg, 150 mg and 200 mg film-coated tablets provides no clinical added value (CAV V) compared to ruxolitinib in 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 and who have been treated with ruxolitinib.