Constellation Pharmaceuticals receives fast track tag for myelofibrosis med

Constellation Pharmaceuticals announced that it has received Fast Track designation from the FDA for CPI-0610 in treatment of myelofibrosis based on preliminary results from the Company’s Phase 2 study, MANIFEST. Constellation is developing CPI-0610 with the goal of providing a new treatment option for patients with MF who have experienced disease progression after treatment with Jakafi, the only approved therapy for MF. Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial, which is exploring CPI-0610’s potential both as a monotherapy and as a combination therapy with Jakafi. As previously reported, preliminary data demonstrated clinical activity, such as spleen volume reduction, symptom improvement, increase in hemoglobin levels, and conversion to transfusion independent status in a patient who was transfusion dependent. Constellation recently expanded the MANIFEST study to include a third cohort, designed to evaluate CPI-0610 as a first-line therapy in combination with ruxolitinib in JAK 1/2-inhibitor-naive MF patients.
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