Rye Brook, N.Y. (December 18, 2020) – The U.S. Food and Drug Administration (FDA) today announced approval of selinexor (Xpovio®) for adults with multiple myeloma who have had at least one prior type of treatment. Selinexor is used in combination with the chemotherapy drug bortezomib (Velcade®) and the corticosteroid dexamethasone in these patients.
LLS supported development of selinexor with over $4 million in grants for research in multiple myeloma and other forms of blood cancer. Despite therapeutic advances, there is no cure for multiple myeloma and a pressing need for additional treatment options for patients who are living with this progressive disease. Multiple myeloma accounts for nearly one in five new blood cancer diagnoses in the United States each year, with most of the 30,000 new cases diagnosed in people in their mid-60s.
Today’s approval expands the availability of selinexor to patients in earlier stages of multiple myeloma. Selinexor was previously approved for patients whose multiple myeloma had returned or was progressing despite treatment with at least four prior therapies. Selinexor is an oral therapy that works by helping the body’s cells retain proteins they need to fight cancer.
The approval was based on results from the phase 3 BOSTON study. Patients who received treatment once-a-week with a combination of selinexor, bortezomib and dexamethasone had a 47% improvement in progression-free survival (PFS) compared to patients on the standard twice-a-week treatment with bortezomib and dexamethasone with a median PFS of 13.9 months compared to 9.4 months. The triple combination patients had fewer clinic visits and received less of the chemotherapy and steroid drugs overall. However, the combination treatment is associated with some serious, though usually manageable side effects. A full report on this study has been published (Grosicki et al., 2020. Lancet 396: 1563-1573).
LLS continues to support the development of new life-extending therapies for patients with multiple myeloma by funding the best foundational research as well as clinical studies through our robust academic grant and venture philanthropy programs.