by Dr. C.H. Weaver M.D. updated 7/2019
The FDA has granted accelerated approval to Xpovio (selinexor) for use in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma. The approval in July 2019 follows prior Fast Track designation to the oral Selective Inhibitor of Nuclear Export (SINE) compound in 2018.
The initial Fast Track designation was based on the multi-center, single-arm Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study in approximately 122 patients with heavily pretreated, penta-refractory multiple myeloma.
About Xpovio - Selinexor
Xpovio (selinexor-KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Xpovio functions by binding with and inhibiting the nuclear export protein XPO1 leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.
This current approval was based on data from a study that evaluated the effectiveness of the combination therapy in 83 patients with relapsed or refractory multiple myeloma. Overall 25.3% of patients responded to Xpovio and the median duration of response was 3.8 months.
The most frequently reported side effects included neutropenia, a low count of neutrophils, neutropenia, thrombocytopenia, anemia, vomiting, nausea, fatigue, diarrhea, fever, and decreased appetite.
The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review
- Food and Drug Administration. FDA approves new treatment for refractory multiple myeloma. July 03, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-refractory-multiple-myeloma. Accessed July 03, 2019.