Multiple Myeloma Drug ‘Xpovio’ Passes With FDA Accelerated Approval

As reported in Biospace, xpovio (selinexor), a drug used to treat relapsed refractory multiple myeloma, received accelerated approval by the Food and Drug Administration this July.

About Multiple Myeloma

Multiple myeloma does not currently have a cure, and patients often find themselves running through the various available options, growing resistant to each new treatment as the disease continues to advance. This drug is for those who have already exhausted traditional treatments, with the tablet offered only to those who have already received extensive treatment of at least four prior methods, and a cancer that has exhibited resistance to such options.

Multiple myeloma is a cancer that forms tumors in the bones, specifically effecting plasma cells in bone marrow. These plasma cells are responsible for making antibodies to combat infections, but for people with multiple myeloma, their healthy blood cells are replaced by masses of cancerous myeloma cells producing disfunctional antibodies. This causes patients to experience bone pain, nausea, infections, kidney problems, low blood count, and many other daily ailments.

Accelerated Approval

The treatment has received the go-ahead of an ‘accelerated approval.’ This drug designation is given to medicine used to address unmet needs for serious conditions, but which still must undergo more trials. Xpovio has the side effects of low white blood cell counts and numerous other blood cell related issues, as well as nausea, fatigue, fever, constipation, and more.
The drug passed with the response rate of 25.3% for 3.8 months on average, with trials including 83 patients who received the drug, xpovio, alongside dexamethasone.
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