An advanced PARP inhibitor, Lynparza is the first targeted treatment which is being developed by the companies to exploit DNA damage response (DDR) pathway deficiencies to kill cancer cells.
The drug is indicated as an adjuvant treatment for deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer patients who were previously treated with neoadjuvant or adjuvant chemotherapy.
Based on an FDA-approved companion diagnostic (CDx) test for Lynparza, the patients eligible for receiving the treatment with Lynparza will be selected.
The regulatory approval was based on data obtained from the parallel group, double-blind, placebo-controlled, global Phase III OlympiA trial, which evaluated the therapy’s efficacy and safety.
The Breast International Group led the study, along with NRG Oncology, the Frontier Science & Technology Research Foundation, AstraZeneca, and Merck.
In this study, Lynparza met the primary endpoint of invasive disease-free survival (IDFS).
It showed a statistically significant improvement in IDFS along with reducing the risk of recurrences of invasive breast cancer.
AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “This important approval gives early-stage high-risk breast cancer patients in the US with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today.
“Lynparza reduced the risk of disease recurrence in these patients, and now new data confirm it also significantly extended patients’ lives versus placebo.
“These data underline the importance of germline BRCA testing as soon as possible after diagnosis to help identify patients who may be eligible for Lynparza.”
The therapy has already been approved in the EU, US, Japan as well as in many other countries for the same indication.
It has also been approved to treat patients with locally advanced breast cancer in the EU and Japan.