The Temporary Use Authorization is a specifically French procedure issued by the ANSM. It allows patients to benefit from early access to innovative treatments, that fulfil major medical needs, before the marketing authorisation is obtained. Requested by a Pharmaceutical firm, the cohort ATU along with a therapeutic use protocol enables supervise the follow-up and the treatment administration and specifies the data to be collected.
Consequently RCTs supported Janssen-Cilag in the analysis of data collected for the daratumumab cohort ATU, in the treatment of multiple myeloma.
Two reports – designed for the ANSM and that met specific requirements, were written to present the clinical, efficacy and safety data of the 180 patients included in the ATU from May 9 to June 20, 2016 and followed up until July 7, 2016.