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

This is the first approval of a PARP inhibitor as a first-line maintenance treatment for BRCA-mutant gynecologic cancers.
BY Brielle Benyon
PUBLISHED December 19, 2018
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.

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