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.

 

Publication
ATU DARA Poster AFCROs 2018

The Temporary Use Authorization (Autorisation Temporaire d’Utilisation – ATU) is a specific French regulatory procedure granted by the ANSM, allowing patients early access to innovative treatments that address a significant medical need before they are placed on the market. Requested by the pharmaceutical company, the cohort ATU, together with a therapeutic use protocol, ensures appropriate supervision of treatment administration and defines the data to be collected.

RCTs supported Janssen‑Cilag in the analysis of the data collected as part of the cohort ATU obtained for daratumumab in the treatment of multiple myeloma.

j&j

 

Two reports, intended for the ANSM and meeting precise regulatory requirements, were produced to present the clinical, efficacy and safety data from the 180 patients included in the ATU between May 9 and June 20, 2016, with follow‑up until July 7, 2016.

See the full publication

Publication

ATU DARA Poster AFCROs 2018