ANSM grants first cohort ATU to a new indication of an authorised medicine

On 11 March 2019, the French National Agency for Medicines and Health Products Safety (ANSM) granted the first cohort Temporary Authorisation for Use (ATUc) for a medicine that already has a marketing authorisation since 2014 in a different indication. Thanks to this first ATUc, some patients with advanced ovarian cancer will be able to benefit from maintenance treatment with Lynparza® (olaparib) after a first line of platinum-based chemotherapy.

This is the first ATUc for an extension indication according to the early access and care scheme provided for in Article 65 of the Social Security Financing Act for 2019 (see Legal Update 2019 Social Security Financing Act introduces new healthcare measures). This system allows early access to medicines for a different indication than the one for which they already have a marketing authorisation.

Lynparza® (olaparib) has a marketing authorisation in the United States since 19 December 2018 for the same indication as the one covered by the ATUc. In Europe, a request for the extension of the marketing authorisation has been under examination since 19 August 2018. France is the rapporteur for the evaluation of this dossier.

Pending the availability of this anti-cancer treatment within the framework of the EU marketing authorisation, patients in France will be able to access this innovative treatment through this ATUc as of March 2019.

The practical terms of use of Lynparza® in the context of this ATUc will soon be detailed on the ANSM website and the conditions of access to treatment will be specified in the therapeutic use protocol accompanying this ATUc.

A prior version of this post was originally published by the same authors in Practical Law - Life Sciences, March 2019 Issue (Thomson Reuters).