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

NEWTON, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) seeking approval for XPOVIO (selinexor), its first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy.  Karyopharm expects a decision from the FDA regarding this sNDA before the end of the first quarter of 2021.

“This sNDA acceptance brings us one 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. “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 one 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.”

XPOVIO has been previously approved by the FDA for the treatment of patients with penta-refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma. Provided marketing approval is granted by the FDA for this third oncology indication, Karyopharm plans to continue to commercialize XPOVIO in the U.S. using its existing commercial infrastructure. The Company also plans to submit a Marketing Authorization Application to the European Medicines Agency later this year for this same indication.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.