Selinexor granted FDA priority review

Following a recent fast track designation approval, selinexor (KPT-330) has now been granted priority review by the US Food and Drug Administration (FDA) for obtaining drug approval for the treatment of penta-refractory multiple myeloma (MM) patients. To receive selinexor, eligible patients must be refractory to at least one immunomodulatory drug, one proteasome inhibitor, daratumumab, glucocorticoids as well as to the last treatment they have received.

The decision was based on results from the STORM study, a phase IIb single arm clinical trial, which measured the overall response rate (ORR) of penta-refractory MM patients treated with selinexor (80 mg) and low dose dexamethasone (20 mg). The results of the trial, presented at the 2018 Society of Hematologic Oncology (SOHO) Annual Meeting, showed an ORR of 26.2% and a median overall survival (OS) of 8.6 months.

Selinexor is administered orally and is believed to function by inducing apoptotic cell death, mainly in myeloma rather than healthy cells. Selinexor binds to the nuclear export protein XPO1 (also known as CRM1), which results in accumulation of tumor suppressor proteins in the nucleus.

The FDA is expected to make a decision on approval of the agent by April 6, 2019.

References

1. OncLive online. FDA Grants Selinexor Priority Review for Multiple Myeloma. https://bit.ly/2NxMU9Q. [Assessed Oct 9 2018].
2. Healio online. FDA grants priority review to selinexor for penta-refractory myeloma. https://bit.ly/2Ps0ZaZ. [Assessed Oct 9 2018].