NEW YORK – The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) on Tuesday approved AstraZeneca and Merck's Lynparza (olaparib) as adjuvant monotherapy or combined with endocrine therapy for HER2-negative, high-risk, early-stage breast cancer patients who harbor germline BRCA1 or BRCA2 mutations and who have previously received neoadjuvant or adjuvant chemotherapy.
The approval, which grants marketing authorization to the PARP inhibitor across Great Britain, is based on data from the Phase III OlympiA trial, in which Lynparza improved invasive disease-free survival versus placebo. Patients randomized to Lynparza had a 42 percent reduction in the risk of invasive breast cancer recurrences, second primary invasive cancers, or death versus patients randomized to placebo.
Last year, the US Food and Drug Administration also approved adjuvant Lynparza for this patient population, simultaneously approving Myriad Genetics' BRACAnalysis CDx as a test to identify patients with germline BRCA1/2 mutations who are eligible for treatment.
The European Commission followed suit and approved the PARP inhibitor for the same indication last month, as did Japanese regulators.