FDA EIR - Kendra Sweet, M.D. - May 17, 2018

An FDA inspection of clinical investigator Kendra Sweet, M.D., located at H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida, was conducted from May 14 to May 17, 2018. This initial inspection was initiated by CDER’s Office of Scientific Investigations under Compliance Program 7348.811, which governs Clinical Investigators and Sponsor-Investigators. The purpose of the inspection was to assess Dr. Sweet's conduct as a clinical investigator for Protocol STML-401-0114, sponsored by Stemline Therapeutics, Inc. This protocol involves the investigational drug tagraxofusp (SL-401) in patients with Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm. The inspection covered Stages 1, 2, and 3 (Phases I and II) of the study, which enrolled a total of 28 subjects who received the test article out of 38 screened. During the inspection, the investigator reviewed Institutional Review Board (IRB) documentation, informed consents, Case Report Forms (CRFs), and source documents including study worksheets and medical records. Specific data points reviewed included biopsy results, bone marrow results, laboratory results, primary endpoint data (Complete Response), and Serious Adverse Event (SAE) reporting. Notably, the FDA inspection concluded without any significant objectionable conditions being observed. Consequently, no FDA Form 483 (Inspectional Observations) was issued, indicating compliance with regulatory requirements. As no significant issues or violations were identified, no specific corrective or required actions were mandated by the FDA following this inspection.