First Drug Approved to Treat BRCA-Mutated Metastatic Breast Cancer

In January, the U.S. Food and Drug Administration approved the use of Lynparza to treat metastatic breast cancer patients whose tumors have a specific inherited genetic 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 Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence.
In 2014, the FDA approved Lynparza, also known as olaparib, to treat certain patients with ovarian cancer. Now the drug can be used to treat patients with BRCA1- and BRCA2-mutated, HER2-negative metastatic breast cancer who previously have been treated with chemotherapy. Patients with HR-positive breast cancer should have been treated with a prior hormonal therapy or be considered inappropriate for endocrine treatment.
BRCA1 and BRCA2 genes produce proteins that suppress tumors. These proteins help repair damaged DNA. Normally, they work to prevent tumor development. However, genetic mutations can lead to certain cancers, including breast cancers.
The drug Lynparza works to block an enzyme called PARP. Like BRCA proteins, PARP also helps repair damaged DNA. When the enzyme is blocked, the DNA inside cancerous cells with damaged BRCA genes may be less likely to be repaired. That leads to cell death, and it could slow down or stop tumor growth.
“This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types,” Pazdur said.
While Susan G. Komen did not financially support the development of Lynparza, Komen has funded more than $32.4 million in PARP inhibitor research. Nearly $6 million specifically focused on olaparib.