The US Food and Drug Administration (FDA) has accepted and granted priority review of a supplemental new drug application (sNDA) for Lynparza to be used in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer.
Breast cancer
Lynparza is an oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to potentially kill cancer cells. It is currently approved in the US as a capsule form for the treatment of ovarian cancer.
This sNDA submission — made by AstraZeneca and Merck as part of their global strategic oncology collaboration to jointly develop and commercialise Lynparza — represents the first submission for a PARP inhibitor outside ovarian cancer and the third indication submission for Lynparza in the US.
The submission is based on the positive outcomes of the Phase III OlympiAD trial, which was published in the New England Journal of Medicine.
