March 2022: The Food and Drug Administration has approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) high-risk early breast cancer who have received neoadjuvant or adjuvant chemotherapy. Patients must be chosen for olaparib therapy based on an FDA-approved companion diagnosis.
OlympiA (NCT02032823), an international randomised (1:1), double-blind, placebo-controlled study of 1836 patients with gBRCAm HER2-negative high-risk early breast cancer who completed definitive local treatment and neoadjuvant or adjuvant chemotherapy, received approval. Patients were given either olaparib tablets 300 mg orally twice day for a year or a placebo. At least 6 cycles of neoadjuvant or adjuvant chemotherapy comprising anthracyclines, taxanes, or both were required of patients. According to local recommendations, patients with hormone receptor positive breast cancer were authorised to continue concurrent treatment with endocrine therapy.
Invasive disease-free survival (IDFS) was the primary effectiveness goal, defined as the period from randomization to the date of first recurrence defined as invasive loco-regional, distant recurrence, contralateral invasive breast cancer, new malignancy, or death from any cause. In terms of IDFS, the olaparib arm had 106 (12%) incidents compared to 178 (20%) in the placebo arm (HR 0.58; 95 percent CI: 0.46, 0.74; p0.0001). At three years, patients who received olaparib had an IDFS of 86 percent (95 percent CI: 82.8, 88.4), while those who received placebo had an IDFS of 77 percent (95 percent CI: 73.7, 80.1). Overall survival was another efficacy objective. The olaparib arm had 75 fatalities (8%) while the placebo arm had 109 deaths (12%) (HR 0.68; 95 percent CI: 0.50, 0.91; p=0.0091). Patients in the Lynparza group had a statistically significant improvement in IDFS and OS when compared to those in the placebo arm.
Nausea, lethargy (including asthenia), anaemia, vomiting, headache, diarrhoea, leukopenia, neutropenia, decreased appetite, dysgeusia, dizziness, and stomatitis were the most prevalent side responses (10%) in the OlympiA research.
The recommended dose of olaparib is 300 mg twice a day, with or without food, for up to a year.