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Karyopharm Submits Supplemental New Drug Application to FDA for XPOVIO® (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Line of Therapy
NEWTON, Mass., May 20, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced it
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"NEWTON, Mass., May 20, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for XPOVIO® (selinexor), its first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a new treatment for patients with previously treated multiple myeloma.\n “Earlier this year, we reported positive top-line results from the pivotal Phase 3 BOSTON study evaluating the combination of XPOVIO (selinexor), once-weekly Velcade® (bortezomib) and low-dose dexamethasone (SVd) as a second line treatment for patients with relapsed or refractory multiple myeloma,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “The full study results, which were included in the sNDA, will be presented on May 29, 2020 at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. In the BOSTON study, the SVd arm demonstrated a statistically significant reduction in the risk of disease progression or death, along with a 47% increase in median progression-free survival, as well as a significantly higher overall response rate, as compared to the standard Velcade and dexamethasone (Vd) regimen. If approved, we believe XPOVIO could become an important addition to the treatment paradigm for patients with relapsed or refractory multiple myeloma, and we look forward to working with the FDA during the review process.” Karyopharm also plans to submit a Marketing Authorization Application to the European Medicines Agency requesting approval for XPOVIO in this same indication later this year. The abstract for the Phase 3 BOSTON clinical data to be presented at the 2020 ASCO annual meeting and can be found on ASCO’s website, here. 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 the...