20 July 2022 - FDA fast track designation and European Commission orphan medicinal product designation underscore the significant need for new treatment options for myelodysplastic syndromes.

Karyopharm Therapeutics today announced new regulatory designations for eltanexor, a novel oral, selective inhibitor of nuclear export investigational compound being studied for the treatment of myelodysplastic syndromes: (i) the U.S. FDA has granted fast track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high, or very high risk myelodysplastic syndromes; (ii) the European Commission adopted the Committee for Orphan Medicinal Products opinion to designate eltanexor as an orphan medicinal product for the treatment of myelodysplastic syndromes in the European Union.

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