The European Commission (EC) has granted orphan medicinal product designation for selinexor for the treatment of myelofibrosis (MF).
Karyopharm Therapeutics and the Menarini Group’s selinexor was granted orphan drug designation in MF by the U.S. Food and Drug Administration (FDA) in May 2022.
Karyopharm is currently evaluating selinexor, a first-in-class XP01 inhibitor, as monotherapy in patients with previously treated MF, and in combination with ruxolitinib in treatment-naïve patients.
In December 2021, Karyopharm and Menarini entered into an exclusive licensing agreement whereby Menarini is responsible for commercializing all current and future indications of NEXPOVIO (selinexor) in the European Economic Area, United Kingdom and Switzerland, CIS countries, Turkey and Latin America. Stemline Therapeutics B.V., a wholly owned subsidiary of Menarini, is leading all commercialization activities in Europe.
“We are very pleased to receive orphan medicinal product designation from the EC for selinexor for the treatment of myelofibrosis,” said Reshma Rangwala, MD, PhD, chief medical officer of Karyopharm. “Building on our recent orphan drug designation from the FDA, this recognition continues to reinforce the significant unmet need for a drug with a novel mechanism of action like selinexor for this devastating disease. Our clinical plans remain on track, and we look forward to the continued development of selinexor in MF.”
“Myelofibrosis is a difficult-to-treat and complex disorder of the bone marrow with limited therapeutic options and we are committed to bringing novel treatments to patients through our collaboration with Karyopharm. We are excited about the potential to bring selinexor to myelofibrosis patients in Europe, pending positive study read-outs and regulatory approval,” said Olivia del Puerto, MD LMS, head of Medical Affairs Oncology – EMEA of Menarini.