AstraZeneca and Merck’s Lynparza (olaparib) Receive EU’s Approval as a Monotherapy to Treat Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

Shots:

• The approval is based on P-III OlympiAD trial assessing Lynparza (300mg, bid) vs CT (capecitabine, eribulin or vinorelbine) in 302 patients with germline BRCA1- and/or BRCA2-mutated, HER2-negative (HR-positive or triple negative) breast cancer 
• The P-III study results: 42% reduction in the risk of disease progression or death; PFS (7.0mos. vs 4.2mos.); ORR (52% vs 23%)
• Lynparza (olaparib) is a PARP inhibitor targeted to block DNA damage response in cells/tumors harboring a deficiency in homologous recombination repair (HRR). In Jul,2017 AZ and Merck globally collaborated to co-develop and co-commercialize Lynparza

Click here to read full press release/ article | Ref: AstraZeneca | Image: AstraZeneca