The FDA has approved Lynparza, co-developed by AstraZeneca and Merck (MSD), for adjuvant use in high-risk early breast cancer patients who have already been treated with either chemotherapy or surgery.
Lynparza works by targeting proteins that BRCA-mutated tumors need to repair their DNA, offering a therapy option that kills cancer cells through synthetic lethality, in which mutations in two genes together result in cell death.
In the trial that led to the approval — OlympiA phase 3 trial published in The New England Journal of Medicine — Lynparza significantly reduced recurrence of invasive breast cancer tissue, second cancers or death by 42% versus the placebo. The trials also showed clinically meaningful improvement in secondary endpoint of overall survival, and that the tolerability profile was in line with prior clinical trials.
Because breast cancer is so common, addressing the specificities of each type of cancer is crucial. Lynparza will now be an additional treatment option for germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.
“Today’s approval of olaparib [Lynparza] is great news for patients with a specific inherited form of breast cancer…OlympiA has shown that identifying a BRCA1/2 mutation in women with high risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients,” said Andrew Tutt, Global Chair of the OlympiA Phase 3 trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London.
Lynparza was first approved in 2014 to treat advanced ovarian cancer. In July 2017, AstraZeneca and Merck & Co. announced a global strategic oncology collaboration to co-develop and co-commercialize Lynparza for multiple cancer types.
Lynparza is approved in the U.S., EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy. In the EU, the indication includes those with locally advanced breast cancer.
