The US Food and Drug Administration (FDA) has expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasised), and whose tumours have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a ‘BRCA’ gene mutation.
Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.
‘This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,’ explained Richard Pazdur, MD, Director of the FDA’s Oncology Centre of Excellence, and Acting Director of the Office of Haematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research.
‘This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.’
Lynparza is a PARP (poly ADP-ribose polymerase) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumour growth.
