FDA approves first treatment for breast cancer with a certain inherited genetic mutation

FDA expanded on January 12 the approved use of olaparib (Lynparza—AstraZeneca) tablets to include the treatment of patients with certain types of breast cancer that have spread and whose tumors have a specific inherited genetic mutation. This is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation. Patients are selected for treatment with olaparib based on an FDA-approved genetic test, the BRACAnalysis CDx (Myriad Genetic Laboratories). "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, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in 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." Olaparib, a PARP inhibitor, was first approved by FDA in 2014 to treat certain patients with ovarian cancer and is now indicated for the treatment of patients with germline breast cancer susceptibility gene (BRCA) mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been previously treated with chemotherapy. Common adverse effects of olaparib include low levels of red blood cells, low levels of certain white blood cells, nausea, fatigue, vomiting, common cold , respiratory tract infection, influenza, diarrhea, joint pain, unusual taste sensation, headache, indigestion, decreased appetite, constipation, and inflammation and sores in the mouth. Severe adverse effects include development of certain blood or bone marrow cancers and inflammation in the lungs. FDA has also expanded the approval of the BRACAnalysis CDx to include the detection of BRCA mutations in blood samples from patients with breast cancer.