Karyopharm Therapeutics Inc. – FDA EIR, Feb 28, 2020

An FDA Bioresearch Monitoring (BIMO) inspection of Karyopharm Therapeutics Inc., located in Newton, MA, was conducted from February 24-28, 2020. This surveillance inspection, initiated by the FDA's Center for Drug Evaluation and Research, focused on Karyopharm's responsibilities as the sponsor for clinical study KCP-330-009, involving the investigational drug Selinexor, under the regulatory oversight of the FD&C Act and the BIMO Compliance Program. Although no formal Inspectional Observations (Form FDA 483) were issued during this inspection, several discussion points were raised with company management. These included the omission of two subjects with non-qualifying hemoglobin waivers from the major protocol deviation list, a significant delay in approving one such waiver, and an adverse event (breast cancer leading to mastectomy) that was not classified as serious. Additionally, the Data Safety Monitoring Board (DSMB) Charter contained ambiguous language regarding meeting frequency. The company's CEO acknowledged these items and committed to reviewing and addressing them. The inspection also noted improvements in pharmacovigilance procedures since a previous 2017 FDA inspection, which had identified issues with evaluating drug safety data and adverse event reporting. The current assessment found no issues with Karyopharm's updated pharmacovigilance processes.