Karyopharm’s selinexor delay could speed approval

At first glance a three-month delay to selinexor’s US FDA approval decision should be bad news for its developer, Karyopharm. But the group’s stock rose 30% today on hopes – however slim – that the multiple myeloma project might still be in line for accelerated approval by its new PDUFA date of July 6. Last month an FDA panel appeared to have put a quick go-ahead completely out of reach, voting to wait for results from the open-label Boston study before making a call on selinexor; data are due in late 2019 or early 2020. Since the adcom, Karyopharm has submitted more data to the FDA, and Leerink analysts speculated that these might have come from the Boston trial. Toxicity concerns could still stop selinexor from getting the approval and mean that even if it does, it might remain a last-ditch option. The project is under review for treatment of relapsed/refractory multiple myeloma patients who have received at least three prior therapies; Boston tests a combo with Velcade and dexamethasone in earlier-line relapsed patients. Selinexor is forecast to bring Karyopharm $1.2bn by 2024, according to EvaluatePharma – numbers that are looking increasingly unrealistic.

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