Posted by Michael Wonder on 02 Mar 2019
Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer
1 March 2019 - AstraZeneca and MSD today announced that the CHMP of the EMA has adopted a positive opinion, recommending the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
The positive opinion is based on data from the randomised, open-label, Phase III OlympiAD trial, which tested Lynparza against the physician’s choice of chemotherapy.
