FDA Accepts Supplemental New Drug Application for Selinexor as Multiple Myeloma Treatment

July 21, 2020

Karyopharm announced that the agency has accepted for filing its supplemental New Drug Application for selinexor as a second-line treatment for multiple myeloma.

The FDA has accepted Karyopharm’s supplemental New Drug Application (sNDA) for selinexor’s (Xpovio) as a new treatment for multiple myeloma (MM) in patients who have had at least 1 prior line of therapy, according to a press release.

Selinexor is Karyopharm’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Karyopharm expressed that it expects the FDA’s decision on the sNDA by the end of the first quarter of 2021.

The federal agency has recently approved selinexor for treatment of penta-refractory MM and relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in June 2020.

Selinexor works by selectively binding to and inhibiting the nuclear export protein exportin 1, referred to as XPO1 or CRM1. The drug blocks the nuclear export of tumor suppressor and growth regulatory and anti-inflammatory proteins in order to accumulate these proteins in the nucleus and boost anti-cancer activity.

Additionally, the drug is currently being assessed in ongoing clinical trials spanning various cancer indications, such as backbone therapy in combination with already approved myeloma therapies (STOMP), liposarcoma (SEAL) and endometrial cancer (SIENDO), as well as others.

With potential use in the United States for MM treatment, Karyopharm also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for conditional approval of selinexor for this indication.

The most common adverse events (AEs) in individuals with MM associated with selinexor are thrombocytopenia, fatigue, nausea, anemia, and decreased appetite, among others.

“This sNDA acceptance brings us 1 step closer to providing access to XPOVIO for a significantly larger patient population battling multiple myeloma,” said Sharon Shacham, PhD, MBA, founder, president, and chief scientific officer of Karyopharm in a statement.

“If approved, we believe XPOVIO will become an important new, oral, once-weekly treatment option, used in combination with once-weekly Velcade®, for patients with multiple myeloma after at least 1 prior line of therapy. We look forward to working closely with the FDA during their review process and we sincerely thank the many patients, caregivers, and physicians whose immense contributions have helped us achieve this latest milestone,” Shacham concluded.

Reference:

  1. U.S Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Line of Therapy. News Release. Karyopharm; July 20, 2020. Accessed July 21, 2020. https://investors.karyopharm.com/news-releases/news-release-details/us-food-and-drug-administration-accepts-karyopharms-0.