Lynparza OK'd as First-Line Maintenance of BRCA-Mutated Advanced Ovarian CA
The indication was approved based on results from the SOLO-1 clinical trial, which included a total of 391 patients.
The Food and Drug Administration (FDA) has approved Lynparza (olaparib; AstraZeneca) for the maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor is already approved to treat certain breast, epithelial ovarian, fallopian tube or primary peritoneal cancers based on an FDA-approved companion diagnostic. The new approval was supported by data from the randomized, double-blind, placebo-controlled, multicenter SOLO-1 (NCT01844986) trial that compared olaparib with placebo in patients with BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy (N=391). Patients were randomized to either olaparib 300mg twice daily or placebo.
The primary efficacy outcome was progression-free survival (PFS) according to RECIST 1.1. The data showed a statistically significant improvement in investigator-assessed PFS with olaparib vs placebo (olaparib: not reached vs placebo: 13.8 months; hazard ratio [HR] 0.30, 95% CI, 0.23-0.41; P<.0001). Overall survival data were not mature at the time of PFS analysis.
Nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection, influenza, nasopharyngitis, bronchitis, constipation, dysgeusia, decreased appetite, and dizziness, among others, were the most common adverse reactions seen in the olaparib arm.
In addition, the FDA has concurrently approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) to identify eligible patients with germline BRCA mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
Lynparza is available as 50mg capsules in 112-count bottles and as 100mg and 150mg tablets in 60- and 120-count bottles.
For more information call (800) 236-9933 or visit Lynparza.com.