Posted by Michael Wonder on 26 Feb 2018
Lynparza receives positive EU CHMP opinion in platinum-sensitive relapsed ovarian cancer
23 February 2018 - AstraZeneca and MSD’s new Lynparza tablet formulation recommended for maintenance therapy regardless of BRCA status.
AstraZeneca and Merck & Co. today announced that the CHMP of the EMA has adopted a positive opinion, recommending a marketing authorisation of Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. Lynparza is recommended for treatment in this setting regardless of patients’ BRCA mutation status.
The CHMP recommendation is based on two randomised trials, SOLO-2 and Study 19, which showed Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.
