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FDA Approvals, News & UpdatesMultiple Myeloma

Xpovio a New FDA-Approved Drug for Patients with Multiple Myeloma

August 2019 Vol 5 No 4

In July 2019, the FDA approved Xpovio (selinexor; from Karyopharm Therapeutics), a nuclear export inhibitor, for use in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma after 4 or more therapies, whose disease did not respond to those therapies, including 2 or more proteasome inhibitors, such as Velcade (bortezomib) or Kyprolis (carfilzomib); 2 or more immunomodulatory drugs, such as Revlimid (lenalidomide) or Pomalyst (pomalidomide); and an anti-CD38 monoclonal antibody, such as Darzalex (daratumumab).

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

The FDA approved Xpovio based on a clinical ­trial of patients with multiple myeloma who had previously received at least 4 therapies, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

Treatment with Xpovio plus dexamethasone showed good overall results, with patients responding to treatment within an average of 4 weeks, and the average length of response was almost 4 months.

Xpovio is associated with a risk for serious side effects to a fetus, blood complications, and thromboembolism.

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Last modified: August 28, 2019

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