FDA Approves Lynparza for High-Risk Early Breast Cancer

The FDA has approved AstraZeneca’s and Merck’s Lynparza (olaparib) as an adjuvant treatment for women with germline BRCA-mutated HER2-negative high-risk early breast cancer who have previously received chemotherapy.

The approval was supported by a phase 3 study, which showed that Lynparza reduced the risk of invasive breast cancer recurrences, second cancers and death by 42 percent when compared against placebo. In addition, patients taking Lynparza saw improvements in overall survival of 32 percent vs. placebo.

Lynparza, an oral poly ADP-ribose polymerase inhibitor, is FDA-approved for several cancer indications. The blockbuster earned $2.7 billion for AstraZeneca and $989 million for Merck last year.