Karyopharm: ODAC urges FDA to wait for BOSTON study results before approval

Karyopharm Therapeutics Inc. announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee met to discuss the New Drug Application for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export compound. The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of 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. The ODAC voted 8 to 5 recommending that the FDA wait for the results from Karyopharm’s randomized, open-label, Phase 3 BOSTON study evaluating selinexor in patients with relapsed or refractory multiple myeloma, before making a final decision regarding approval. The BOSTON study is evaluating selinexor in combination with Velcade and low-dose dexamethasone compared to bortezomib and low-dose dexamethasone in patients with multiple myeloma who have had one to three prior lines of therapy. Importantly, in the selinexor arm of the study, both selinexor and bortezomib are administered once per week while in the control arm, bortezomib is administered at its currently indicated, twice per week schedule. Patient enrollment in the BOSTON study is now complete and top-line data are expected by the end of 2019 at the earliest, or into 2020, pending progression-free survival events, a primary endpoint in this trial. “While we are disappointed with ODAC’s recommendation to delay the potential approval of selinexor, we plan to work with the FDA to evaluate the best path forward as they continue to review our NDA. Karyopharm remains committed to improving the outcomes of patients with cancer, including those with relapsed refractory multiple myeloma,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “Patients with triple class refractory multiple myeloma have disease which has progressed following treatment with the most effective myeloma drugs approved to date and are in desperate need of new treatment options. Karyopharm has assembled and submitted a compelling, comprehensive clinical data package to the FDA supporting the request for accelerated approval for selinexor. We are committed to working with the FDA, patients, and the myeloma community with the goal to provide selinexor as an option for those patients with no other options of known clinical benefit.”

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