The Food and Drug Administration has approved olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.
The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) to identify patients who are eligible for olaparib.
Approval of olaparib was based on improvement in progression-free survival (PFS) in the phase 3 SOLO-1 trial of 391 women with BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line, platinum-based chemotherapy. Patients were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily or placebo.
Estimated median investigator-assessed PFS was not reached in the olaparib arm and was 13.8 months in the placebo arm (hazard ratio, 0.30; 95% confidence interval, 0.23-0.41; P less than .0001). Overall survival data are not yet mature.
The most common adverse reactions in women who received olaparib in SOLO-1 were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
The recommended olaparib dose is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg, the FDA said in a press statement.
Olaparib is marketed as Lynparza by AstraZeneca Pharmaceuticals.