Recently, AstraZeneca's breast cancer treatment drug Lynparza (olaparib) has been approved by the US FDA for the treatment of cancer with or suspected of germline BRCA mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2). And patients with metastatic breast cancer who have received chemotherapy.
It is worth mentioning that Lynparza is not only the first PARP inhibitor approved for breast cancer, but also the first PARP inhibitor for the treatment of breast cancer patients with BRCA mutations.
According to relevant data, breast cancer is one of the most common causes of death in female cancer patients. Among them, about 20%-25% of hereditary breast cancer patients and 5%-10% of any type of breast cancer patients have BRCA mutations.
Lynparza (olaparib) is a PARP inhibitor that exploits defects in the DNA repair pathway to make DNA mutations in cancer cells with damaged BRCA genes difficult to return, leading to cell death, slowing or preventing tumor growth.
The safety and efficacy of Lynparza for the treatment of breast cancer has also been confirmed in a clinical study called OlympiAD.
OlympiAD is a randomized, open-label, multicenter, phase III clinical trial conducted in 302 patients with HER2-negative metastatic breast cancer carrying BRCA1 or BRCA2 germline mutations and evaluated Lynparza tablets (300 mg twice daily) The efficacy and safety of standard care chemotherapy (capecitabine, vinorelbine, eribulin) compared to the doctor's choice. In this study, the proportion of triple-negative breast cancer (TNBC) and hormone receptor-positive (ER+ and/or PR+) breast cancer was 1:1. The primary endpoint of the study was progression-free survival (PFS) assessed by the blind independent independent review (BICR), with secondary endpoints including overall survival (OS), worsening of disease or time to death (PFS2), and objective response rate (PFS2). ORR), health-related quality of life (HRQoL).
The data showed that the PFS of the Lynparza-treated group achieved a statistically significant and clinically significant increase in the risk of disease progression or mortality by 42% compared with the standard chemotherapy group (median PFS: 7.0 months vs 4. 2 months; HR = 0.58; 95% CI: 0.43-0.80; p = 0.0009), reaching the primary endpoint of the study.
In addition to the treatment of breast cancer, in the United States, Lynparza was previously approved for the treatment of patients with advanced ovarian cancer who had previously received three- or multi-line chemotherapy and carried a harmful or suspected gBRCA mutation. In the European Union, Lynparza has been approved as a Monotherapy for the maintenance of platinum-sensitive recurrent BRCA mutations (germline mutations or somatic mutations) in high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in adults.
It is also known that while Lynparza is approved, the FDA has also approved Myriad Genetics' BRACAnalysis CDx, which identifies BRCA mutations in blood samples from breast cancer patients for screening patients eligible for Lynparza.
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