The Israeli Ministry of Health has approved Xpovio (selinexor), in combination with the corticosteroid dexamethasone, for the treatment of people with multiple myeloma who have received three or more prior therapies, and who failed to respond to at least one immunomodulatory agent, one proteasome inhibitor, and one CD38 inhibitor.
Xpovio also has won approval in Israel for the treatment of adults with diffuse large B-cell lymphoma (DLBCL) who received at least two prior lines of systemic therapy.
Karyopharm Therapeutics, the therapy’s developer, had previously entered a distribution agreement with Promedico for the commercialization of Xpovio in Israel and the Palestinian Authority. A commercial and marketing license allowing Xpovio to enter Israel’s market is expected in the next few months.
“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,” Sharon Shacham, PhD, founder, president, and CEO of Karyopharm, said in a press release.
Xpovio is a first-in-class oral inhibitor of the XPO1 protein, a nuclear transporter that is produced in greater amounts by cancer cells to enable them to escape the action of tumor suppressor proteins. By preventing the exit of tumor suppressors from the cell nucleus, it can lead to cancer cell death.
The therapy’s approval in Israel for multiple myeloma patients was based on data from the STORM Phase 2b trial (NCT02336815). Participants in that study had received at least three prior lines of therapy and had failed to respond to three classes of myeloma treatments: an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and a CD38 inhibitor.
Results demonstrated that more than one-quarter of the patients (26.2%) responded to Xpovio treatment, and that 39.3% at least did not see their disease progress.
“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,” Schacham said.
A combination of Xpovio plus dexamethasone also gained accelerated approval in the U.S. based on STORM findings, but for a more heavily treated patient population — individuals who received four prior lines of therapy, failed to respond to at least two PIs, two IMiDs, and one CD38 inhibitor, and showed disease progression on their last therapy.
In Europe, Xpovio was recommended for conditional approval for a similar heavily treated population. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency. The committee’s recommendations are generally accepted by the European Commission, which makes the final decisions. A decision on Xpovio’s approval in the EU is anticipated by April.
Additionally, the therapy is being evaluated in several clinical trials for other cancer indications. These studies include the SEAL trial (NCT02606461), assessing Xpovio for liposarcoma, and the SIENDO trial (NCT03555422), testing the therapy for endometrial cancer. The STOMP trial (NCT02343042) is evaluating Xpovio in combination with approved myeloma therapies in the U.S. and Canada.
Other studies have been planned or are currently ongoing, including ones that are evaluating Xpovio in combination with approved therapies in a variety of tumor types.
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