Karyopharm Therapeutics (NASDAQ: KPTI) has announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking accelerated approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis (MF).
According to Karyopharm, it has requested priority review of the application, which, if granted, could result in a six-month review process.
In a statement, Reshma Rangwala, MD, PhD, CMO and head of research of Karyopharm, commented, “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. 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.”
