Karyopharm to Seek Accelerated Approval for Selinexor in Myelofibrosis

The proposed supplemental New Drug Application centers on findings from the randomized SENTRY study, which compared the combination therapy against ruxolitinib alone. According to the company, the regimen demonstrated rapid and sustained spleen volume reduction, alongside promising signals regarding overall survival and disease modification. If successful, this would mark the first combination therapy approved for myelofibrosis, introducing a new class of treatment to a field currently reliant on JAK inhibitors.

Karyopharm will seek Priority Review status, which could shorten the FDA’s target action window to six months. To verify long-term clinical benefit, the company plans to utilize ongoing survival data from the SENTRY trial. While the trial remains blinded to maintain integrity, the results have already been presented at both the American Society of Clinical Oncology Annual Meeting and the European Hematology Association Congress. CEO Richard Paulson noted that the firm is working with urgency to meet the August submission deadline, aiming to address significant unmet needs for the estimated 20,000 patients living with the condition in the United States.