Selinexor in combination with bortezomib and dexamethasone is used for adult patients with multiple myeloma who have received at least 1 prior therapy.
In December 2020, the FDA approved selinexor (Xpovio, Karyopharm Therapeutics) in combination with bortezomib and dexamethasone for adult patients with multiple myeloma who have received at least 1 prior therapy.
Multiple myeloma is one of the most common types of blood cancer in the United States, with more than 32,000 new cases each year and over 140,000 patients living with the disease, according to a Karyopharm Therapeutics. It is currently incurable despite recent therapeutic advances, with most patients’ disease continuing to progress following treatment with currently available therapies.
Selinexor received an accelerated FDA approval in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, according to the press release.
The new approval is based on data from the phase 3 BOSTON study, which enrolled 402 patients with RRMM who had received 1 to 3 prior lines of therapy.
According to the press release, investigators found that selinexor in combination with bortezomib and dexamethasone had a 47% increase in median progression free survival and demonstrated a significantly greater overall response rate compared to the Velcade plus dexamethasone arm.