The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval for AstraZeneca and Merck’s (MSD outside the US and Canada) Lynparza (olaparib) as adjuvant therapy for high-risk early breast cancer patients.
The treatment is intended for breast cancer patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative who have previously received neoadjuvant or adjuvant chemotherapy.
A PARP inhibitor, Lynparza is co-developed and co-marketed by Merck and AstraZeneca.
The CHMP adopted a positive opinion based on findings from the global, parallel-group, placebo-controlled, double-blind Phase III OlympiA clinical trial.
The trial analysed the safety and efficacy of Lynparza compared to placebo as adjuvant therapy for gBRCAm, HER2-negative high-risk early breast cancer patients.
According to the results, Lynparza offered a statistically significant and clinically meaningful improvement in the primary endpoint of invasive disease-free survival (IDFS).
It showed a 42% decline in the risk of invasive breast cancer recurrences, second cancers or mortality compared to placebo.
The treatment with Lynparza also provided a statistically significant and clinically meaningful improvement in the secondary endpoint of overall survival, offering a 32% decline in mortality risk versus placebo.
Lynparza’s safety and tolerability profile in the trial was consistent with those reported in previous studies.
Merck Research Laboratories global clinical development head, senior vice-president and chief medical officer Dr Eliav Barr said: “Patients with germline BRCA-mutated, HER2-negative early breast cancer will often develop breast cancer at an earlier age than those without BRCA mutations, impacting people in their prime.
“The positive opinion brings us closer to our goal of offering a much-needed new treatment option to these patients in Europe.”
In November 2020, Lynparza (olaparib) received approval from the European Commission for treating prostate cancer and ovarian cancer in the EU.