EMA panel backs approval of AstraZeneca, Merck & Co.'s PARP inhibitor Lynparza in breast cancer

AstraZeneca and partner Merck & Co. on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of the PARP inhibitor Lynparza (olaparib) as monotherapy for the treatment of HER2-negative locally advanced or metastatic breast cancer in adults with germline BRCA1/2 mutations. Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, said the decision "further underscores the critical need to identify patients' BRCA status, in addition to hormone receptor and HER2 expression status, as part of the management of this disease." 

The filing was backed by data from the Phase III OlympiAD study of 302 patients with germline BRCA1- or BRCA2-mutated, HER2-negative metastatic breast cancer. Results showed that Lynparza-treated patients had significantly improved progression-free survival (PFS) versus chemotherapy, at 7 months and 4.2 months, respectively. The drug was also associated with an objective response rate of 59.9 percent, compared to 29 percent for chemotherapy. 

Lynparza is currently approved in over 60 countries, including the EU and the US, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. The drug is also cleared in several countries, including the US and Japan, for use in patients with germline BRCA-mutated HER2-negative metastatic breast cancer previously treated with chemotherapy.

Meanwhile, AstraZeneca and Merck recently announced that the PARP inhibitor met the main goal of the Phase III POLO study by significantly extending PFS versus placebo in patients with germline BRCA-mutated metastatic pancreatic cancer. 

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