FDA Grants Fast Track Designation to Selinexor in Myelofibrosis Treatment

The US Food and Drug Administration granted Fast Track Designation to the development program of selinexor for patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis.

In June 2023, Karyopharm, the manufacturer of the drug, initiated XPORT-MF-034, a pivotal phase III clinical trial, to assess the efficacy and safety of a once-weekly dose of selinexor 60 mg plus ruxolitinib in Janus kinase inhibitor-naïve patients with myelofibrosis. The results presented at the 2023 ASCO® Annual Meeting showed that selinexor plus ruxolitinib was effective in certain subgroups of patients with myelofibrosis.

Source: PR Newswire