FDA Approves Lynparza for Maintenance Treatment of BRCA-Mutant Gynecologic Cancers

The Food and Drug Administration (FDA) approved Lynparza (olaparib) 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 a complete or partial response to frontline platinum-based chemotherapy.

This is the first approval for a PARP inhibitor in the first-line setting for BRCA-mutant ovarian cancer, according to AstraZeneca, the manufacturer of the drug.

“The expanded approval of Lynparza based upon the SOLO-1 trial has the potential to change medical practice and reinforces the importance of knowing a woman’s BRCA status at diagnosis,” Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a statement.

Those with germline BRCA-mutated advanced epithelial, ovarian, fallopian tube or primary peritoneal cancer should be selected for therapy based on a newly approved diagnostic, BRACAnalysis CDx.

The approval was based on results from the phase 3 SOLO-1 trial, which compared Lynparza (260 patients) with placebo (131 patients) in patients with BRCA-mutant advanced ovarian, fallopian tube or primary peritoneal cancer after they were already treated with a platinum-based chemotherapy.

Estimated median progression-free survival was not reached patients treated with Lynparaza compared with 13.8 months in the placebo arm. The FDA noted that at the time of the trial’s analysis of progression-free ad overall survival data were not mature.

The most common side effects included nausea, fatigue, abdominal pain, vomiting, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia (distorted sense of taste), decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia and stomatitis.

“SOLO-1 is truly a landmark trial in gynecologic cancer. This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer. The ability to offer this important first-line maintenance treatment option to eligible patients may slow down or even stop the natural course of disease progression,” Kathleen Moore, M.D., co-principal investigator of the SOLO-1 trial and associate director for clinical research at the Stephenson Cancer Center at the University of Oklahoma, said in a statement.