FDA EIR - SEAGEN INC. - October 04, 2019

An FDA inspection of Seattle Genetics, Inc. was conducted from October 1-4, 2019, focusing on the company's conduct and oversight of clinical study protocol SGN22E-001 for the investigational drug enfortumab vedotin. This PDUFA BLA Sponsor inspection, guided by Compliance Program 7348.810 for Sponsors, Contract Research Organizations, and Monitors, aimed to evaluate various aspects including trial master file, site monitoring, drug safety reporting, and record keeping. While no official Form FDA 483 (Inspectional Observations) was issued, the inspection concluded with verbal discussions highlighting three key issues. Firstly, the timing and frequency of site monitoring visits at U.S. locations did not consistently align with the company's Clinical Monitoring Plan. Secondly, a non-English speaking subject, consented via a short form and translator, was not subsequently provided with a copy of the informed consent or an IRB-approved summary in their native language. Lastly, Seattle Genetics submitted IND safety report documentation late to its IND holder, Astellas, on two occasions, which in turn caused Astellas to submit Individual Case Safety Reports (ICSRs) late to the FDA. Management acknowledged these concerns, expressing an intention to evaluate and improve relevant processes, though no formal written response was required.