The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) to treat BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer patients.
AstraZeneca and Merck & Co (MSD) are together developing and commercialising Lynparza, a first-in-class PARP inhibitor.
The sNDA was based on results obtained from the Phase III, double-blind, placebo-controlled, multicentre, parallel group OlympiA trial.
The trial is evaluating the safety and efficacy of Lynparza tablets as against placebo as adjuvant treatment in germline BRCAm high-risk HER2-negative early breast cancer patients.
These patients have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
The Breast International Group is leading the trial in collaboration with the Frontier Science & Technology Research Foundation, NRG Oncology, AstraZeneca and MSD.
iDFS defined as time from randomisation till date of first loco-regional or distant recurrence or new cancer or death from any cause, is the primary goal of the trial.
Lynparza’s safety and tolerability profile in the trial was consistent with that observed in previous studies.
The therapy secured approval in Japan, the US, EU and several other countries to treat germline BRCAm, HER2-negative, metastatic breast cancer patients who earlier received chemotherapy based on results from the OlympiAD Phase III trial.
AstraZeneca and MSD announced a global strategic oncology partnership in July 2017 to co-develop and co-commercialise Lynparza and mitogen-activated protein kinase (MEK) inhibitor Koselugo (selumetinib) for different types of cancer.
Together, Lynparza and Koselugo will be developed in combination with other potential new medicines and as monotherapies.
The companies will also develop the therapies in combination with their respective PD-L1 and PD-1 medicines, independently.