Supplemental NDA submission for Selinexor Plus Ruxolitinib in Myelofibrosis Planned Under Accelerated Approval Pathway
“Patients with myelofibrosis have waited too long for meaningful innovation,” said Richard Paulson, President and Chief Executive Officer of Karyopharm. “We are grateful to the FDA for its thoughtful and collaborative engagement in helping define a rigorous path forward. If approved, selinexor in combination with ruxolitinib has the potential to become the first approved combination therapy for patients with myelofibrosis, incorporating a novel class of therapy. We believe this represents a potentially transformative opportunity for patients and a defining moment in Karyopharm’s history as we work with urgency toward our planned August sNDA submission.”
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