According to an article recently published in Targeted Oncology, the FDA approved olaparib (Lynparza), a product of AstraZeneca Pharmaceuticals, in March of this year. Lynparaza will be used as adjuvant treatment for adult patients with HER2 negative, BRCA-mutated breast cancer that has not spread to other areas (metastasized).
Adjuvant treatment is one that is added to curative therapy with the goal of preventing a recurrence of cancer. Germline is defined as cells that pass their genetic material to offspring.
About the Trial
The FDA’s approval resulted from the OlympiA clinical trial, an international trial consisting of 1,836 patients who were diagnosed with negative high-risk gBRCAm HER2 cancer. These patients had completed their treatment which was either neoadjuvant or adjuvant.
Neoadjuvant treatment is delivered prior to the primary therapy in an effort to reduce the size of a tumor or kill metastasized cancer cells.
Patients in the double-blind trial were chosen randomly to receive either 300 mg twice-daily oral dose of Lynparaza for up to a year or a placebo. Trial participants must have completed a minimum of six cycles of either neoadjuvant or adjuvant chemotherapy such as taxanes (Taxol and Taxotere), anthracyclines, or both.
Invasive disease-free survival (IDFS) was the principal endpoint of the trial. IDSF was defined collectively as the date of randomization to the date of death from any cause. At the three-year interval, IDFS was 86% for patients treated with Lynparaza and 77% for the placebo cohort.
With respect to overall survival, 75 deaths were reported in the Lynparaza cohort, while there were 109 deaths in the placebo group. The risk of second cancers, cancer recurrences, or death was reduced by 42%.
Common side effects (10%) included but were not limited to anemia, headache, diarrhea, low white blood counts (leukopenia) low neutrophil counts (neutropenia), and nausea.
The FDA worked in collaboration with Swissmedic and Health Canada on the review. The FDA’s application received priority review stating that it will respond within a six-month period rather than the standard ten-month review.
