Case 2: Efficacy and Safety of Fedratinib in High Risk MF

EP: 1.Case 1: Hydroxyurea-Resistant Polycythemia Vera (P. Vera)

EP: 2.Case 1: Diagnosis of P. Vera

EP: 3.Case 1: Risk Assessment in P. Vera

EP: 4.Case 1: Initial Treatment Options for Low Risk P. Vera

EP: 5.Case 1: Considerations for Cytoreductive Therapy in P. Vera

EP: 6.Case 1: Treatment Options after Hydroxyurea Failure in P. Vera

EP: 7.Case 1: Treatment Approaches for High Risk P. Vera

EP: 8.Case 1: Role of Symptomatic Improvement in Overall Outcome in MF

EP: 9.Case 2: High Risk Myelofibrosis (MF)

EP: 10.Case 2: Prognostic Models of MF

EP: 11.Case 2: Predictors of Response to Ruxolitinib in High Risk MF

EP: 12.Case 2: Safety and Efficacy of Ruxolitinib in High Risk MF

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EP: 13.Case 2: Efficacy and Safety of Fedratinib in High Risk MF

EP: 14.Case 2: Considerations for Optimizing Therapy in High Risk MF

EP: 15.Case 3: Essential Thrombocythemia (ET)

EP: 16.Case 3: Risk Assessment in ET

EP: 17.Case 3: Individualized Therapy for ET

EP: 18.Case 3: Molecular Profile and Initiation of Therapy in ET

EP: 19.Case 3: Front Line Therapy Options in ET

EP: 20.Case 3: Disease Progression and Transformation in ET

Jamile M. Shammo, MD: Let’s move on to the fedratinib phase 3 trial, JAKARTA. This is the randomized placebo-controlled trial for patients who have intermediate- and high-risk MF [myelofibrosis], splenomegaly, and a platelet count of at least 50,000 per mm3. Patients were randomized to either placebo or fedratinib. The primary end point was spleen response: 35% reduction at week 24. The majority of those patients, as you’ve seen with the ruxolitinib, had spleen response of some sort. But those who had less than 35% were 36% of the patients. It was a little higher at the 500-mg dosing. In the placebo group, most of the patients had increase in that percentage. In fact, there was an abstract that Dr Claire Harrison presented. For those who had a platelet count above 100,000 per mm3, the responses seemed to be a little better. For those who had a platelet count between 50 and 100 per mm3, 36% is reasonable as well. The heme and nonheme toxicities are what you see here. Everybody who has to start this medicine needs to be aware of the heme toxicity. These are grades 3 and 4. The nonheme toxicity would include some GI [gastrointestinal] toxicity as well, but grades 3 and 4 seem to be very small and tolerable with supportive care. Because of the grade, the cases of Wernicke encephalopathy that had been reported earned it the black box warning. All the patients who have to be started on fedratinib have to be evaluated as such and have their thiamine level checked prior to and periodically throughout treatment.

Ruben Mesa, MD: Jamile, that was a wonderful walk-through of the complex data for myelofibrosis.

This transcript has been edited for clarity.