FDA expands use of Lynparza to include breast cancer with specific inherited genetic mutation

The US Food and Drug Administration (FDA) has given the green light to an expansion of use of olaparib tablets (Lynparza) to now include the treatment of patients with certain types of breast cancer that have metastasized and whose tumours have a specific inherited genetic mutation.

This newly approved expanded use means that Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor approved to treat breast cancer and the first time that any drug has been approved for the treatment of metastatic breast cancer with germline breast cancer susceptibility gene (BRCA) mutation.

“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,” said Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center 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.”

Furthermore, the FDA also expanded the approval of the BRACAnalysis CDx, an approved companion diagnostic to Lynparza, which will now include the detection of BRCA mutations in blood samples from patients with breast cancer.

This companion diagnostic test will be used in the patient selection process for treatment with Lynparza.