The U.S. Food and Drug Administration (FDA) has approved the combination of Xpovio (selinexor) tablets and corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) under the accelerated approval program therapy. All those patients who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immuno-modulatory agents, and an anti-CD38 monoclonal antibody.
“While there is no cure for multiple myeloma, there are Food and Drug Administration, FDA-approved treatments to target cancer and slow down the spread of the disease. Often over time, patients can exhaust all available treatments and still see their disease progress,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Efficacy was evaluated in 83 patients with RRMM who were treated with Xpovio in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%.
Common side effects of patients taking Xpovio in combination with dexamethasone include a low white blood cell count (leukopenia), a low count of neutrophils, a type of white blood cell (neutropenia), low count of platelets (thrombocytopenia) and low amount of red blood cells (anemia). Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections, and low blood sodium levels (hyponatremia).
The USFDA advises health care professionals to monitor patients for low blood counts, platelets and sodium levels. Patients should avoid taking Xpovio with other medications that may cause dizziness or confusion and avoid situations where dizziness may be a problem. They are also advised to optimize the patient’s hydration status, blood counts and other medications to avoid dizziness or confusion. Females of reproductive age and males with a female partner of reproductive potential are advised to use effective contraception during treatment with Xpovio. Women who are pregnant or breastfeeding should not take Xpovio because it may cause harm to a developing fetus or newborn baby.
