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
Karyopharm Therapeutics Inc. (KPTI)
Last karyopharm therapeutics inc. earnings: 2/13 07:00 am
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Source: GlobeNewswire
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. “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 (AS
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KPTI
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- 2/29/24 - Miss
KPTI
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- 4/23/24 - Form 4
- 4/19/24 - Form ARS
- 4/19/24 - Form DEFA14A
- KPTI's page on the SEC website