FDA Approves Olaparib as First-Line Maintenance Therapy for BRCA-Mutated Advanced Ovarian Cancer

2018Year12Month19On [date], AstraZeneca and MSD jointly announced that the U.S. Food and Drug Administration (FDA) has approved olaparib for use in patients with deleterious or suspected deleterious germline or somaticBRCAMutation (gBRCAmorsBRCAm) adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after first-line platinum-based chemotherapy, for first-line maintenance treatment. These patients must have previously receivedFDAApproved Companion Diagnostic Tests.

Olaparib became the first approved forBRCAFirst-Line Maintenance Therapy for Advanced Ovarian Cancer with MutationsPARPinhibitor. This approval is based on pivotalIIIPhaseSOLO-1Positive results of the trial. The trial results confirmed that, in patients who achieved complete or partial response after platinum-based chemotherapy,BRCAIn patients with advanced ovarian cancer harboring mutations, olaparib reduced the risk of disease progression or death compared with the placebo group70%（HR 0.30 [95% CI 0.23-0.41]，p <0.0001). The safety profile of olaparib was consistent with that observed in previous trials.

Executive Vice President, AstraZeneca Oncology Business UnitDave Fredrickson“Ovarian cancer patients are often at an advanced stage of the disease at diagnosis, with a poor prognosis.”SOLO-1The trial results indicate that, as first-line maintenance therapy, olaparib canBRCAReduced Risk of Disease Progression or Death in Patients with Advanced Ovarian Cancer Harboring Mutations70%. “Today’s approval represents a significant step forward, bringing us closer to our goal of helping these patients achieve long-term disease remission.”

Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development, MSD Research LaboratoriesRoy Baynessaid: "Based onSOLO-1As a result of the trial, olaparib has received new approval again, which is expected to change medical practice and further enhance the understanding of women at the time of diagnosis.BRCAThe Importance of Genetic Status. We will continue to collaborate with AstraZeneca, jointly committed to improving patient treatment outcomes.”

InSOLO-1In the trial, via median41months of follow-up, the olaparib group did not reach progression-free survival (PFS) median, while the median in patients in the placebo groupPFSFor13.8months. In the olaparib group, there were60%patients who3No disease progression within the year, while the proportion in the placebo group was27%。SOLO-1Relevant data from the trial have been published in2018Year10Month21in the online edition of The New England Journal of Medicine.

Deputy Director of Clinical Research, Stephenson Cancer Center, University of Oklahoma, Oklahoma City, USA,SOLO-1Co-Principal Investigator of the TrialKathleen MooreSaid: “SOLO-1is a truly landmark gynecologic oncology trial. This approval may change how we treatBRCAmutation in patients with advanced ovarian cancer. By providing this important first-line maintenance therapy to eligible patients, we aim to slow down or even halt the natural progression of the disease.”