Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion granted accelerated approval to Xpovio (selinexor) tablets in com­bi­na­tion with the corticosteroid dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed refractory multiple myeloma (RRMM) 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 immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body.

“While there is no cure for multiple myeloma, there are FDA-approved treat­ments to target the cancer and slow down the spread of the disease. Sadly, 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. “Today we approved a treat­ment under our accelerated approval pro­gram that provides a treat­ment option for patients with multiple myeloma with no avail­able ther­apy.”

Multiple myeloma is cancer that begins in plasma cells (white blood cells that produce anti­bodies) and may also be referred to as plasma cell myeloma. Abnormal plasma cells build up in the bone marrow, forming tumors in many bones of the body. As more anti­bodies are made, it can cause blood to thicken and keep the bone marrow from making enough healthy blood cells. The exact causes of multiple myeloma are unknown, but it is more common in older people and African Americans.

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%. The median time to first response was four weeks, with a range of one to ten weeks. The median duration of response was 3.8 months. The efficacy evaluation was sup­ported by addi­tional in­for­ma­tion from an ongoing, ran­dom­ized trial in patients with multiple myeloma.

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).

Health care professionals are advised 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. Health care professionals are advised to optimize the patient’s hydration status, blood counts and other medications to avoid dizzi­ness or confusion. The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive poten­tial 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. Xpovio must be dispensed with a patient Medication Guide that describes im­por­tant in­for­ma­tion about the drug’s uses and risks.

Xpovio in com­bi­na­tion with dexa­meth­a­sone was granted accelerated approval, which enables the FDA to approve drugs for serious con­di­tions to fill an unmet medical need based on an end­point that is reason­ably likely to predict a clin­i­cal benefit to patients. Further clin­i­cal trials are required to verify and describe Xpovio’s clin­i­cal benefit.

The FDA granted this appli­ca­tion Fast Track desig­na­tion. Xpovio also received Orphan Drug desig­na­tion, which provides incentives to assist and en­cour­age the devel­op­ment of drugs for rare diseases. The FDA granted the approval of Xpovio to Karyopharm Therapeutics.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and se­cu­ri­ty of human and veterinary drugs, vaccines and other biological prod­ucts for human use, and medical devices. The agency also is responsible for the safety and se­cu­ri­ty of our nation’s food supply, cosmetics, dietary supple­ments, prod­ucts that give off electronic radi­a­tion, and for regulating tobacco prod­ucts.

Source: Food and Drug Admin­istra­tion.