On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm).

SOLO-1

The approval was based on the double-blind, placebo-controlled, multi-center SOLO-1 (NCT01844986) trial randomising patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy to receive either olaparib (N=260) or placebo (N=131) in a 2:1 fashion. The primary efficacy endpoint was investigator-reported (IR) progression-free survival (PFS) by RECIST 1.1.

The median IR-PFS was not reached (NR) in patients treated with olaparib vs 13.8 months in the placebo arm (HR=0.30; 95% CI, 0.23-0.41; P<0.0001). At the time of the data cut-off for the IR-PFS, the overall survival data were not yet matured.

Safety

Common adverse reactions of any grade occurring in ≥10%patients treated with olaparib in the SOLO-1 study included nausea, fatigue, abdominal pain, vomiting, anaemia, diarrhoea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnoea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.

FDA-approved test

Concurrently with the FDA approval of Lynparza for maintenance treatment of gBRCAm or sBRCAm ovarian cancer patients, the FDA approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) for the identification of gBRCAm in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients. The BRACAnalysis CDx test was validated by the same SOLO-1 trial.

Full prescribing information Lynparza®.