FDA approves Xpovio regimen for patients with relapsed or refractory multiple myeloma
The FDA today approved selinexor in combination with corticosteroid dexamethasone for the treatment of relapsed or refractory multiple myeloma, according to press releases from the agency and the manufacturer.
The approval of selinexor (Xpovio, Karyopharm Therapeutics), a nuclear export inhibitor, applies to adults with multiple myeloma who have received at least four previous therapies and whose disease is resistant to at least two proteasome inhibitors, two immunomodulatory drugs and an anti-CD38 monoclonal antibody.
“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,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA release. “Sadly, often over time, patients can exhaust all available treatments and still see their disease progress. 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 approval was based on results from the phase 2b STORM study, which analyzed selinexor in combination with dexamethasone among a subgroup of 83 patients with relapsed refractory multiple myeloma.
Results showed an overall response rate of 25.3% among patients in the subgroup.
Median time to first response was 4 weeks (range, 1-10) and the median duration of response was 3.8 months.
Common adverse events associated with the combination include leukopenia, neutropenia, thrombocytopenia, anemia, vomiting, nausea, fatigue, diarrhea, fever, decreased appetite, constipation, upper respiratory infections and hyponatremia.
“With today’s accelerated approval of Xpovio by the FDA, patients with heavily pretreated multiple myeloma will now have a new therapeutic option to treat their disease,” Sharon Shacham, PhD, MBA, founder, president and chief scientific officer of Karyopharm Therapeutics, said in the manufacturer’s release. “Discovering, developing and securing FDA approval for Xpovio with its novel mechanism of action over the past decade required the dedication of many people, including the patients, caregivers and physicians involved in our clinical trials, along with the many employees at Karyopharm. We are tremendously grateful for everyone’s contributions to this important milestone, and we look forward to the next stage in our pursuit of improving the lives of patients with cancer.”