Benzinga | Feb 4, 2021 07:20AM EST

Karyopharm Announces XPOVIO Receives Regulatory Approval in Israel for the Treatment of Patients with Multiple Myeloma and Diffuse Large B-Cell Lymphoma

Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that its partner Promedico Ltd., a member of the Neopharm Group, has received a principal approval letter from the Israeli Ministry of Health, Israel's regulatory agency responsible for the approval of new medicines, granting the approval of XPOVIO(r) (selinexor) for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma (DLBCL). The approved indications for XPOVIO are a) in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and b) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Karyopharm expects Promedico to receive a registration license providing commercial and marketing authorization for XPOVIO in Israel during the second quarter of 2021. Separately, today's announcement follows Karyopharm's recently announced adoption of a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending conditional approval for NEXPOVIO(r) (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Karyopharm expects to receive a final decision from the European Commission by April 2021.

"The approval of XPOVIO in Israel represents its first regulatory approval outside the United States and is a tremendous milestone for both Karyopharm and the patients we hope to serve in the future," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "The approval of XPOVIO in Israel further demonstrates our commitment to expand XPOVIO's reach to cancer patients across the globe who are in need of novel therapies. We look forward to continuing to work closely with our dedicated partner, Promedico, and its world-class team to bring XPOVIO to patients in Israel."

Karyopharm has previously entered into an exclusive distribution agreement with Promedico, a member of the Neopharm Group, a leader in launching and marketing novel therapies in Israel, for the commercialization of XPOVIO(r) (selinexor) in Israel and the Palestinian Authority.