Karyopharm wins label expansion for XPOVIO in Multiple Myeloma

 

• Karyopharm Therapeutics (NASDAQ:KPTI) announced that FDA has approved XPOVIO in combination with bortezomib and dexamethasone for patients with multiple myeloma after at least one prior therapy.
• XPOVIO, a first-in-class, oral Selective Inhibitor of Nuclear Export medicine was earlier approved for adult patients with relapsed or refractory MM who have received at least four prior therapies/ at least two proteasome inhibitors/ at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
• The label expansion was based on Phase 3 BOSTON study, which was recently published in the medical journal, The Lancet.
• In addition to MM, XPOVIO is also approved for adults with relapsed or refractory diffuse large B-cell lymphoma, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
• Michael G. Kauffman, MD, PhD, the CEO of Karyopharm said, "We plan to immediately launch XPOVIO in this earlier-line indication by leveraging our established commercial infrastructure and growing account base of academic institutions and community-based oncology practices."
• The company earlier noted the inclusion of three different Xpovio combination regimens in National Comprehensive Cancer Network guidelines for previously treated MM, prompting the RBC analyst Brian Abrahams to note “with key combos now immediately reimbursable by many plans -- we could see shares start to appreciate.”
• After a brief halt, trading of Karyopharm is to resume from 12PM ET.
• https://seekingalpha.com/news/3645797-karyopharm-wins-label-expansion-for-xpovio-in-multiple-myeloma