NEW YORK – The European Commission on Thursday approved AstraZeneca and Merck's PARP inhibitor Lynparza (olaparib) as adjuvant treatment, either alone or combined with endocrine therapy, for high-risk, early-stage HER2-negative breast cancer patients who harbor germline BRCA1/2 mutations and who have previously received neoadjuvant or adjuvant chemotherapy.
The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is based on the results of the Phase III OlympiA trial, in which Lynparza reduced the risk of invasive breast cancer recurrence, new cancers, or death by 42 percent versus placebo. The PARP inhibitor also improved overall survival, reducing the risk of death by 32 percent versus placebo.
The US Food and Drug Administration approved Lynparza for the same indication in March. Simultaneously, the FDA approved Myriad Genetics' BRACAnalysis CDx to identify patients with germline BRCA1/2 mutations who are eligible for treatment.
When the OlympiA data were published in the New England Journal of Medicine last year, oncologists debated whether genetic testing guidelines should be expanded to include BRCA1/2 germline testing for all early-stage breast cancer patients to determine their eligibility for Lynparza. In the US, the National Comprehensive Cancer Network does recommend BRCA1/2 germline testing "to aid in adjuvant treatment decisions with olaparib for high-risk HER2-negative breast cancer."
Beyond the adjuvant indication, Lynparza is also approved in the US and EU, as well as Japan and other regions, as treatment for germline BRCA1/2-mutated metastatic breast cancer patients after treatment with chemotherapy and hormone therapy if their tumors are hormone receptor-positive.