FDA Approves First Drug Specifically for BRCA-mutated Breast Cancer

The US Food and Drug Administration (FDA) has for the first time approved a treatment specifically for a type of breast cancer caused by a mutated BRCA gene. Lynparza (olaparib) is intended for patients who have HER2-negative breast cancer, whose cancer has spread (metastasized), and who have previously been treated with chemotherapy. The FDA also approved the BRACAnalysis CDx genetic test to identify people with breast cancer who have a BRCA gene mutation, and therefore may benefit from treatment with Lynparza.

Lynparza is the first drug of its kind, known as a PARP inhibitor, approved to treat breast cancer. PARP inhibitors work by blocking the action of an enzyme that helps repair DNA. In certain tumor cells, such as those in people with BRCA mutations, blocking this enzyme can lead to cell death. Women who carry BRCA mutations are at a higher risk of developing some types of cancer, including ovarian and breast cancers. Men with this gene mutation are also at a higher risk for breast cancer.

The FDA based its approval on a randomized clinical trial of 302 patients with HER2-negative metastatic breast cancer with an inherited (germline) BRCA mutation. This study measured the length of time from starting treatment until the tumors began growing again. This length of time averaged 7 months for the group taking Lynparza compared with 4.2 months for the group taking chemotherapy. However, it’s not yet clear if the patients who took Lynparza survived any longer than those who took the chemotherapy.

Lynparza and the BRACAnalysis CDx genetic test were first approved by the FDA in 2014 for women with certain types of ovarian cancer. The FDA expanded the approval of Lynparza for breast cancer under its priority review program, which is meant to speed up approval of drugs that would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.

Lynparza is a tablet taken by mouth. Common side effects include low blood counts, nausea and vomiting, fatigue, common cold-like symptoms, respiratory tract infection, flu, joint pain, headache, taste changes, diarrhea, constipation, indigestion, decreased appetite, and mouth sores.

Serious side effects can include the development of a bone marrow disorder, acute myeloid leukemia (a bone marrow cancer), and lung inflammation. Women should not breastfeed while taking Lynparza because it may harm the baby. Women should not get pregnant while taking Lynparza.

Lynparza is marketed by AstraZeneca Pharmaceuticals and BRACAnalysis is manufactured by Myriad Genetic Laboratories, Inc.

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