For the first time, ANSM allows you to quickly access innovative therapies through special permits. The first molecule is olaparib (100 mg and 150 mg tablets). If you already have a Marketing Authorization benefit, you will soon be prescribed for other women with cancer.
The ANSM " Granting the first cohort ATU (ATUc) for drugs that already have marketing authorization with another indication ".
Olaparib (Lynparza 100mg and 150mg tablets) can be prescribed soon As a monotherapy maintenance therapy for adult patients with progressive epithelial ovarian, tubal or primary peritoneal (newly diagnosed FIGO III and IV stage) cancers with BRCA1 / 2 gene mutations "I am concerned about patients." Partial or total response to the first line of platinum-based chemotherapy ".
The US olaparib has already been prescribed as an indications since December 19, 2018. In Europe, AMM extension requests are being investigated since August 19, 2018. This cohort is an ATU (ATUc) intermediate stage. In fact, this ATUc " The efficacy and safety of the drug are given by the laboratory and the result of the treatment test strongly predicted drug. "Says the Ministry of Health.