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Karyopharm Submits New Drug Application to U.S. FDA for XPOVIO® (selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NEWTON, Mass., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced it
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"NEWTON, Mass., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for XPOVIO® (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a new treatment for patients with relapsed or refractory diffuse large B-Cell lymphoma (DLBCL) after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR-T (chimeric antigen receptor modified T cell) therapy. XPOVIO has received both Orphan Drug and Fast Track designations from the FDA for this indication.\n “Earlier this year we reported compelling results from the Phase 2b SADAL study investigating XPOVIO in patients with relapsed or refractory DLBCL. The updated results submitted in the NDA demonstrate a 28.3% overall response rate, including an 11.8% complete response rate, and a median duration of response of over 9 months,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “These data highlight XPOVIO’s potential as a new, first-in-class oral therapy for patients whose DLBCL has progressed following two prior treatments and who have extremely limited treatment options available. The submission of this second NDA is a significant achievement for Karyopharm and brings XPOVIO one step closer to serving an entirely new group of patients. We are sincerely grateful to all of the patients, caregivers and physicians who have contributed to the XPOVIO DLBCL program, and we look forward to providing future updates on the status of this NDA. If approved, XPOVIO would represent the first and only oral regimen to treat patients with relapsed or refractory diffuse large B-cell lymphoma.” Karyopharm also expects to submit a marketing authorization application (MAA) to the European Medicines Agency in 2020 requesting conditional approval for XPOVIO in 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 suppresso...