This program, also known as a named patient program, allows patients and doctors in countries where a medicine is not yet approved or available access to them, provided the medicine is approved in one other country.
Karyopharm Therapeutics, the developer of Xpovio, partnered with Clinigen to open such a program. Under the agreement, Clinigen will distribute and facilitate access to Xpovio in 49 countries across Central and South America, Africa, Asia, and Europe, it announced in a press release.
The therapy will be exclusively available to patients with either multiple myeloma or DLBCL, for whom Xpovio has been approved in the U.S.
Physicians can obtain the details of Xpovio’s named patient program by contacting Clinigen’s customer service team by phone (+44-1932-824-123, or +44-1932-824-100) or by email. Patients interested in accessing Xpovio through the program should speak with their physician.
Xpovio is a first-in-class oral inhibitor of the XPO1 protein, which is produced in abnormally high amounts by cancer cells and enables cells to escape the action of tumor suppressor proteins. By targeting XPO1, it works to increase the amount of tumor suppressor proteins in the nucleus of cells, leading to cancer cell death.
Xpovio is approved in the U.S., in combination with dexamethasone, for people with relapsed or refractory multiple myeloma whose disease is resistant to at least four prior therapies — including at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), and one CD38 inhibitor — and who showed disease progression on their last therapy.
It was also approved for adults with relapsed or refractory DLBCL who received at least two prior lines of treatment.
In Israel, Xpovio is approved for similar indications, though its myeloma approval includes a less heavily treated population — patients who went through three or more prior therapies, and failed to respond to at least one IMiD, one PI, and one CD38 inhibitor.
Xpovio was also recommended for conditional approval in Europe for a myeloma indication similar to the one approved in the U.S. The recommendation, by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, is now being reviewed by the European Commission. A decision is expected by April.
More recently, the U.S. Food and Drug Administration (FDA) approved a triple combination of Xpovio — which includes Velcade (bortezomib) and low-dose dexamethasone — for multiple myeloma patients after at least one line of therapy.
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