When AstraZeneca appeared at ASCO last June to explain how Lynparza reduced the risk of cancer recurrence or death by 42% compared to placebo among a group of patients with BRCA-mutated breast cancer and HER2 negative, investigators pointed out how this could set up a first-in-class endorsement in the early stages of the disease, right after surgery.
That OK is now here, as the FDA has given the PARP inhibitor the green light as an adjuvant therapy in this setting, the company announced Friday evening.
Lynparza can now be prescribed to high-risk patients who have already been treated with chemotherapy, before or after surgery.
Patients with early stage breast cancer with BRCA mutation and HER2-negative germline often have more aggressive disease, noted Roy Baynes, head of global clinical development at Merck, which partners with AstraZeneca on Lynparza.
By knocking out proteins that BRCA-mutated tumors often rely on to repair their DNA, Lynparza represents a targeted therapy option that kills cancer via a mechanism known as synthetic lethality.
Updated results from Olympia – the same trial generating the progression-free survival data that AstraZeneca presented in 2021 – suggest that Lynparza also helped patients live longer, reducing the risk of death by 32% compared to placebo (p=0.0091), the company added.
“These data underscore the importance of germline BRCA testing as soon as possible after diagnosis to identify patients who may be eligible for Lynparza,” said Dave Fredrickson, executive vice president of Oncology Business Unit at AstraZeneca.