First Treatment Approved for Breast Cancer Caused by Specific Gene Mutation

Lynparza (olaparib) has been approved by the U.S. Food and Drug Administration to treat spreading breast cancer caused by a BRCA gene mutation.

The drug is among a class called poly ADP-ribose polymerase (PARP) inhibitors, which are designed to block an enzyme involved in repairing damaged DNA. The hope is that by blocking the repair of cancer cells, the cells will die and slow or stop tumor growth, the FDA said in a news release Friday.

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

More than 250,000 women in the United States are projected to be diagnosed with breast cancer this year, and more than 40,000 will die from it, according to estimates from the U.S. National Cancer Institute. About 5 to 10 percent of people with breast cancer have a BRCA mutation, the FDA said.

Lynparza was evaluated to treat breast cancer in clinical studies involving 302 people. People who took the drug had an average 7 months of progression-free survival, compared to 4.2 months among people who were given only chemotherapy.

Lynparza's most common side effects included low levels of red or white blood cells, nausea, fatigue, vomiting, cold-like symptoms and respiratory tract infections. More serious adverse reactions could include development of certain cancers of the blood or bone marrow, and lung inflammation, the FDA said.

The drug shouldn't be taken by women who are pregnant, hoping to become pregnant or breast-feeding, the agency warned.

Lynparza is produced by the British drugmaker AstraZeneca, whose U.S. headquarters are in Wilmington, Del.

More information

Visit the FDA to learn more.


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