On October 18, 2017 AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) reported that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. A Prescription Drug User Fee Act date is set for the first quarter of 2018 (Press release, AstraZeneca
, OCT 18, 2017, View Source [SID1234520989]).
This is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the US. The sNDA is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine.
Lynparza was first approved in December 2014 as a capsule formulation, making it the first ever PARP inhibitor to be approved. Since then, Lynparza has been used to treat more than 3,000 advanced ovarian cancer patients. Lynparza tablets are currently being tested in a range of tumour types including breast, prostate and pancreatic cancers.
NOTES TO EDITORS
About OlympiAD
OlympiAD is a randomised, open-label, multicenter Phase III trial assessing the efficacy and safety of LYNPARZA tablets (300mg twice daily) compared to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The international trial was conducted in 19 countries across Europe, Asia, North America and South America.
About Lynparza (olaparib)
Lynparza was the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to potentially kill cancer cells. Specifically, in vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.
Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.
About Metastatic Breast Cancer
Approximately one in eight women will be diagnosed with breast cancer in the US, based on 2012 – 2014 data.1 In 2017 this would amount to more than 250,000 women who will be diagnosed with breast cancer.1 Despite treatment options increasing during the past three decades, there is currently no cure for patients diagnosed with metastatic breast cancer and the 5-year relative survival rate for this patient population is currently 26.9%.1,2,3 Thus, the primary aim of treatment is to slow progression of the disease for as long as possible, improving, or at least maintaining, a patient’s quality of life.2
About Germline BRCA mutations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein is either not made or is faulty, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.4