A typically reliable method of securing U.S. approval for a cancer drug these days is to run a small, single-arm clinical trial in patients no longer responsive to all approved therapies. Eke out a modest benefit for patients from the study, and FDA is often willing to greenlight approval.
This is the path Karyopharm Therapeutics is pursuing with its experimental pill selinexor. The small biotech announced Monday evening that 25 percent of multiple myeloma patients responded to treatment with selinexor in a single-arm clinical trial. The median duration of response was 4.4 months.
Karyopharm enrolled into the clinical trial 122 patients with multiple myeloma whose disease continued to advance despite previous treatment with a minimum of five currently available drugs, including the recently approved monoclonal antibody therapy Darzalex.
The most common side effects reported in the study were nausea, vomiting, and reduced appetite, although more specific details were not disclosed by Karyopharm Monday night.
Based on these study results, Karyopharm said it will seek approval of selinexor with the FDA in the second half of the year.
If approved, selinexor sales potentially could top $500 million, Jefferies analyst Maury Raycroft forecast in a research note ahead of Monday’s Karyopharma announcement.
Karyopharm shares closed Monday at $13.08 but were trading up by 27 percent in the after-hours session.
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