FDA Approves New Treatment for Multiple Myeloma


The FDA has granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics) tablets in combination with the corticosteroid dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous therapies and whose disease is resistant to several other treatment types.

“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, MD, Director of the FDA’s Oncology Center of Excellence, in a press statement.

“Today we approved a treatment under our accelerated approval program that provides a treatment option for patients with multiple myeloma with no available therapy,” he added.

This approval was based on data from a study evaluated efficacy of the combination therapy in 83 patients with relapsed or refractory multiple myeloma. By the end of the study, the overall response rate was 25.3%.

The median time to first response was 4 weeks, and the median duration of response was 3.8 months. These data were supported by information from an ongoing trial in patients with multiple myeloma.

Source: US 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.

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