FDA approves Lynparza to treat inherited breast cancer

The US Food and Drug Administration (FDA) has approved the use of AstraZeneca’s Lynparza (olaparib tablets) for the treatment of certain types of breast cancer that have metastasized and those with BRCA gene mutation.

Lynparza is said to be the first poly ADP-ribose polymerase (PARP) inhibitor drug approved for metastatic breast cancer with the specific inherited germline genetic mutation.

The drug is designed to inhibit an enzyme that is known to be associated with repair of damaged DNA, in order to block the DNA repair within tumour cells having damaged BRCA genes, resulting in cell death or potential cessation of tumour growth.

The FDA also approved molecular diagnostic firm Myriad Genetics’ BRACAnalysis CDx genetic test as a companion diagnostic to select patients for treatment using Lynparza.

"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."

FDA Oncology Center of Excellence director Richard Pazdur said: "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.

"This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types."

In 2014, FDA approved Lynparza to treat ovarian cancer patients. The latest approval for BRCA mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer is based on the safety and efficacy data from a randomised 302-patient clinical trial.

The trial is reported to have demonstrated seven months of median progression-free survival with Lynparza, when compared to 4.2 months with chemotherapy alone.