INREBIC (fedratinib) - Disease-related splenomegaly

The Committee deems that the clinical benefit of INREBIC (fedratinib) 100 mg hard capsules remains moderate in the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who have been treated with ruxolitinib.  

Considering:

•  evidence of a superiority of fedratinib compared to the “best therapy available” (BAT) in patients previously treated with ruxolitinib, in terms of ≥ 35% spleen volume reduction in the FREEDOM2 trial, with a statistically significant difference of 29.6% (CI95% = [19.9; 39.4], p<0.0001, ITT population) between the two groups, at the end of cycle 6 compared to baseline,
•  evidence of a superiority of fedratinib compared to BAT in patients previously treated with ruxolitinib, in terms of the percentage of patients with an at least 50% reduction in total symptom score on the MFSAF form, at the end of cycle 6 compared to baseline, with a statistically significant difference of 17.1% (CI95% =[4.8; 29.4], p=0.0033, ITT population) between the two groups,

but:

•  the safety profile of INREBIC (fedratinib) marked by gastrointestinal and haematological (anaemia, thrombocytopenia) adverse events and the occurrence of potential serious cases of Wernicke’s encephalopathy during studies, requiring monitoring before and after treatment with INREBIC (fedratinib),
• the absence of long-term safety data,
• the impossibility of determining the role of INREBIC (fedratinib) compared to OMJJARA (momelotinib), 

The Committee considers that INREBIC (fedratinib) provides no clinical added value (CAV V) in the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who have been treated with ruxolitinib.