Selinexor Gets Priority Review From the FDA for Multiple Myeloma

According to a story from OncLive, the drug development company Karyopharm Therapeutics recently announced that the US Food and Drug Administration has granted Priority Review to the company’s XPO1 inhibitor drug selinexor. The review was granted for treating penta-refractory multiple myeloma. The decision was made following the release of data from a Phase 2b trial in which selinexor was used 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.

About The Study

In the study, the combination of selinexor and dexamethasone was able to produce an overall response rate of 26.2 percent. In addition, the median overall survival time achieved in the study was 8.6 months. These results are from patients with penta-refractory multiple myeloma, which is disease that has often been treated with a number of other therapies, has continued to progress, and has often developed treatment resistance. Patients that displayed even a limited degree of response to the treatment survived considerably longer, with a median overall survival time of 15.6 months. Typically the median ovarall survival time for patients in this group is just 3.6 months.

About Priority Review

Priority Review is a program that allows certain drugs to be a reviewed more quickly by the FDA. The typical review process takes ten months, but under Priority Review, this time is reduced to six. The program is reserved for therapies that either offer significant advantages in treatment effectiveness and safety in comparison to currently available treatments or are expected to satisfy a medical need that is not being met by current treatments.

 


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