FDA Approves Xpovio for Use with Velcade and Dexamethasone in Multiple Myeloma

The Food and Drug Administration has approved oral Xpovio (selinexor) for use with Velcade (bortezomib) and dexamethasone for the treatment of adults with multiple myeloma who have previously received at least one therapy.

This FDA approval was based on findings from the BOSTON study, a phase 3 study with 402 patients with relapsed or refractory multiple myeloma who previously received one to three lines of therapy. Progression-free survival (PFS) in patients assigned Xpovio with Velcade and low-dose dexamethasone was 13.9 months compared with 9.5 months in patients assigned Velcade with dexamethasone, which contributed to a 47% increase in median PFS. These patients also had a significantly greater overall response rate, 76.4% compared to 62.3% respectively.

“New treatments for multiple myeloma remain a critical need for both patients and their treating physicians,” Dr. Paul Richardson, clinical program leader and director of clinical research at Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute and co-senior author of the BOSTON study, said in the release. “As the only approved nuclear export inhibitor that has demonstrated a strong synergistic effect with a proteasome inhibitor such as (Velcade), (Xpovio) has, in my opinion, the potential to meet a current treatment gap for our multiple myeloma patients in need of new therapeutic options.”

Xpovio is a first-in-class oral selective inhibitor of nuclear export medicine, a drug that causes cell death by blocking a particular protein in the body. The drug was previously approved through the FDA’s Accelerated Approval Program to treat adults with relapsed or refractory multiple myeloma who previously underwent at least four therapies, and has disease that is refractory (unresponsive) to at least two immunomodulatory agents, at least two proteasome inhibitors and an anti-CD38 monoclonal antibody.

“Today’s U.S. approval broadens the existing label for Xpovio and allows Karyopharm to offer a new, highly active treatment option to a significantly expanded patient population,” Sharon Shacham, founder, president and chief scientific officer of Karyopharm, said in a press release from the company. “We believe the expanded reach of Xpovio will address a critical need for patients with multiple myeloma given its novel mechanism of action, convenient oral administration and established rapid and sustained efficacy profile.”

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