Advisers urge FDA to delay decision on Karyopharm cancer drug

Advisers to the US drugs regulator have said a decision on whether to approve Karyopharm’s multiple myeloma combination should be delayed until the results of a phase 3 trial, due late this year or in 2020. The FDA’s Oncologic Drugs Advisory Committee (ODAC) was discussing Massachusetts-based Karyopharm’s combination involving selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound. Karyopharm is asking for approval in combination with dexamethasone for patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.
In other words, most of the other approved options out there, such as Takeda’s Velcade (bortezomib), Celgene’s Revlimid (lenalidomide), and Janssen’s Darzalex (daratumumab) respectively. The FDA had granted a priority review lasting only six months, and the manufacturer is seeking approval based on early data, that would need to be confirmed by larger trials. This filing is based on data from Karyopharm’s phase 2b STORM study, testing selinexor and low-dose dexamethasone in 122 heavily pretreated patients refractory to three classes of drugs, and who had been exposed to all five of the most commonly prescribed medicines to treat the disease.