Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application to FDA, seeking approval for Xpovio (selinexor), its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with previously treated multiple myeloma.
“Earlier this year, we reported positive top-line results from the pivotal phase III BOSTON study evaluating the combination of Xpovio (selinexor), once-weekly Velcade (bortezomib) and low-dose dexamethasone as a second line treatment for patients with relapsed or refractory multiple myeloma,” Sharon Shacham, founder, president and chief scientific officer of Karyopharm, said in a statement.
The full study results, which were included in the sNDA, will be presented May 29 during the 2020 American Society of Clinical Oncology virtual scientific program. In the BOSTON study, the SVd arm demonstrated a statistically significant reduction in the risk of disease progression or death, along with a 47% increase in median progression-free survival, as well as a significantly higher overall response rate, as compared to the standard Velcade and dexamethasone regimen.
Karyopharm also plans to submit a Marketing Authorization Application to the European Medicines Agency requesting approval for Xpovio in this same indication later this year. The abstract for the phase III BOSTON clinical data to be presented at the 2020 ASCO annual meeting and can be found here.
