The European Commission (EC) has granted approval for Merck (MSD outside the US and Canada) and AstraZeneca’s Lynparza (olaparib) as monotherapy or along with endocrine therapy for the adjuvant treatment in adults with high-risk, early-stage breast cancer.
The treatment is indicated for people with germline BRCA1/2 mutations (gBRCAm) and have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.
Earlier, these patients received neoadjuvant or adjuvant chemotherapy.
In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) recommended approving the treatment in this setting.
This EC approval was based on findings from the parallel-group, double-blind, placebo-controlled, global Phase III OlympiA clinical trial of Lynparza versus placebo.
It analysed the safety and efficacy of Lynparza in breast cancer patients.
According to the findings, Lynparza was found to offer statistically significant and clinically meaningful invasive disease-free survival (IDFS) improvement.
Furthermore, it lowered invasive breast cancer recurrence, new cancer, or mortality risk by 42%.
The treatment also provided a statistically significant and meaningful improvement in overall survival lowering mortality risk by 32% compared to placebo.
Lynparza’s tolerability and safety profile in the trial was consistent with those reported in previous studies.
A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair.
The US Food and Drug Administration (FDA) approved Lynparza in March for this indication.
Merck Research Laboratories global clinical development head, senior vice-president and chief medical officer Dr Eliav Barr said: “The approval offers patients with germline BRCA-mutated, HER2-negative early-stage breast cancer a new, much-needed treatment option.
“Lynparza as adjuvant treatment can significantly reduce the risk of disease recurrence and death, reinforcing the importance of conducting germline BRCA testing as soon as possible after diagnosis.”