publication date: Jul. 5, 2019
Drugs & Targets
FDA approves Xpovio for refractory multiple myeloma
FDA has granted an accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
The agency granted the approval of Xpovio to Karyopharm Therapeutics.
“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,” Richard Pazdur, 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 a 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.”
Efficacy was evaluated in 83 patients with RRMM who were treated with Xpovio in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was four weeks, with a range of one to ten weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.
Common side effects of patients taking Xpovio in combination with dexamethasone include leukopenia, neutropenia), thrombocytopenia and anemia. FDA granted this application Fast Track designation. Xpovio also received Continue reading FDA approves Xpovio for refractory multiple myeloma
To access this members-only content, please log in.
Institutional subscribers, please log in with your IP
If you're not a subscriber why not join today?
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.