The Food and Drug Administration (FDA) has approved Lynparza (olaparib; AstraZeneca and Merck) tablets for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.
This expanded approval marks Lynparza as the first poly ADP-ribose polymerase (PARP) inhibitor approved to treat breast cancer as well as the first treatment ever for metastatic breast cancer with a BRCA gene mutation. Concurrently, the FDA also expanded the marketing clearance to the companion diagnostic test, BRCAnalysis CDx (Myriad Genetic Laboratories), to help identify patients eligible for treatment with Lynparza.
Lynparza was evaluated in OlympiAD, an open-label, multicenter, randomized trial (N=302) of patients with HER2-negative metastatic breast cancer with a germline BRCA mutation who received either Lynparza or physician’s choice of chemotherapy (capecitabine, vinorelbine, or eribulin). Patients treated with Lynparza demonstrated a median progression-free survival of 7 months vs 4.2 months in patients treated with chemotherapy alone (hazard ratio [HR] 0.58, 95% CI: 0.43, 0.80; P=0.0009).
Lynparza was initially approved by the FDA to treat patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy, and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy. It was co-developed – and will be co-commercialized – by AstraZeneca and Merck, and is available as 100mg and 150mg strength tablets.
For more information call (800) 237-8898 or visit FDA.gov.