Supplemental NDA to FDA submitted for Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis
“Today’s submission is an important step toward our goal of bringing the combination of selinexor plus ruxolitinib to patients with myelofibrosis who continue to face a significant unmet need,” said Reshma Rangwala, M.D., Ph.D., Chief Medical Officer and Head of Research of Karyopharm. “The SENTRY trial generated compelling and consistent results, including rapid, deep and sustained spleen responses across a broad range of patients, together with a promising overall survival signal and important evidence of disease modification. We believe the strength of these data underscores the potential of this novel combination to deliver meaningful long-term benefits and fundamentally change the treatment of patients with myelofibrosis.”
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