Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma

-- European Commission Decision Anticipated within Approximately 60 Days --

NEWTON, Mass. and FLORENCE, Italy, May 20, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received one to three prior lines of therapy.

The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on Karyopharm's NEXPOVIO application. The EC's decision is expected within approximately 60 days following the CHMP recommendation. In December 2021, Karyopharm and Menarini Group entered into an exclusive license agreement to commercialize NEXPOVIO (selinexor) in Europe.

"Despite therapeutic advances, multiple myeloma remains an incurable disease that is difficult to treat," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Today's positive CHMP opinion brings us one step closer to our goal of making NEXPOVIO available to patients globally who may benefit from its novel mechanism of action. We are pleased to have Menarini as a partner in this effort given its commercialization expertise as well as strong heritage and footprint in Europe."

"We are thrilled with the CHMP's recommendation in favor of NEXPOVIO and what it represents for multiple myeloma patients in need of new and innovative treatment options," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "Pending potential marketing authorization from the EC, we will work closely with appropriate authorities to ensure this important treatment can be made available to patients in Europe."

Karyopharm's application is supported by data from the Phase 3 BOSTON study, which evaluated  the SVd triplet regimen in patients with relapsed or refractory multiple myeloma and were published in The Lancet (Grosicki, et al.) in November 2020. This CHMP opinion follows the approval of XPOVIO (selinexor) by the U.S. Food and Drug Administration in December 2020 in the SVd combination in patients with multiple myeloma after at least one prior therapy.