New Treatment for Multiple Myeloma Gains FDA Approval

According to a story from PR Newswire, the drug selinexor (marketed as Xpovio), which was developed by Karyopharm Therapeutics, was recently approved by the US Food and Drug Administration (FDA) as a treatment for the blood cancer multiple myeloma in cases of refractory, relapsed disease in which the patient has received at least four different lines of prior therapy. The treatment is administered in combination with dexamethasone.

About Multiple Myeloma

Multiple myeloma, which is occasionally referred to as plasma cell myeloma, is a blood cancer that affects plasma cells. These are white blood cells that produce antibodies. The overall cause of multiple myeloma is not well understood, however, some risk factors have been identified. These include obesity, family history, smoldering myeloma, and monoclonal gammopathy of undetermined significance. These last two conditions have the potential to develop into multiple myeloma. Symptoms of this cancer include bone pain, infections, anemia, kidney failure, overly thick blood, confusion, fatigue, headaches, and amyloidosis. Treatment includes chemo, stem cell transplant, and other medications for relapsed disease, which is common. Five year survival rate is 49 percent in the US. To learn more about multiple myeloma, click here.

Selinexor and Multiple Myeloma

The new drug is really only expected to be used in certain cases in which the patient has failed to respond to several different types of treatment, such as proteasome inhibitors and immunomodulatory agents. Selinexor nevertheless has the potential to be a critical resource for patients seeking to improve survival, particularly if the patient has exhausted the remaining approaches for treating this dangerous cancer. 

The drug was evaluated in a clinical trial that included 83 patients with the disease. In combination with dexamethasone, selinexor was able to produce an overall response rate of about 25.3 percent. Patients first saw response at a median of four weeks and the duration of response median was 3.8 months. The therapy was cleared for public use with Accelerated Approval, which means that while the drug will get to patients more quickly, more trials are needed to confirm its impact. Selinexor also earned Fast Track and Orphan Drug Designations for the treatment of this disease.


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