WASHINGTON — The FDA approved the PARP inhibitor olaparib (Lynparza) on Wednesday for first-line maintenance therapy in advanced, BRCA-mutated ovarian cancer.
The approval applies to patients with germline or somatic mutations and who respond (complete or partial) to first-line platinum-based chemotherapy. At the same time, the FDA approved the BRACAnalysis CDx as a companion diagnostic test to select patients with germline BRCA mutations for maintenance treatment with olaparib.
The new indication for olaparib followed a report from the randomized, multicenter, placebo-controlled SOLO-1 trial, which showed a 70% reduction in the hazard for disease progression or death in patients randomized to 2 years of olaparib maintenance therapy. Patients in the olaparib arm of the trial had a 3-year progression-free survival (PFS) of 60.4% as compared with 26.9% in placebo-treated patients. Median PFS had yet to be reached in the olaparib group as compared with a median of 13.8 months in the placebo group.
“We feel the SOLO-1 trial has demonstrated an unprecedented improvement in progression-free survival in patients who have a BRCA mutation and advanced ovarian cancer when olaparib is incorporated following platinum-based chemotherapy,” principal investigator Kathleen Moore, MD, of the Stephenson Oklahoma Cancer Center in Oklahoma City, said at the 2018 European Society for Medical Oncology congress in Munich. “It appears that the benefit of olaparib maintenance is extended beyond the 2-year time point during which patients were receiving treatment.”
Adverse events occurring in at least 10% of patients treated with olaparib were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection (and related conditions), constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
The BRACAnalysis CDx also received approval as a companion diagnostic on the basis of its use in the SOLO-1 trial. In prospective and retrospective testing, the assay proved effective for confirming the presence of deleterious germline BRCA mutations.
Olaparib is marketed by AstraZeneca and BRACAnalysis CDx by Myriad Genetics.