The U.S. Food and Drug Administration has now expanded the approved use of Lynparza to include the treatment of patients with certain types of breast cancer that have spread and whose tumors have a specific inherited genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer.
Lynparza also happens to be the first drug that has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
Previously, the agency approved Lynparza for the treatment of patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy, and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to chemo. BRACAnalysis CDx is an FDA-approved test for identifying best responders to Lynparza when used in the fourth-line ovarian cancer setting, but in the maintenance setting, the drug is approved regardless of BRCA mutation status.
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, said: “This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved beyond ovarian cancer. This is significant for breast cancer patients, as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.
”Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories said: “This additional approval for Lynparza represents an important advance for women with HER2-negative metastatic breast cancer with a germline BRCA mutation, which is a difficult-to-treat cancer. Moreover, this approval adds further impetus to our important collaboration with AstraZeneca in developing cancer therapies.”
Breast cancer is the most common form of cancer in the United States. The National Cancer Institute at the National Institutes of Health estimates approximately 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease. Approximately 20-25 percent of patients with hereditary breast cancers and 5-10 percent of patients with any type of breast cancer have a BRCA mutation. BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including breast cancers.
The FDA made its decision based on positive results from the Phase 3 trial, which showed about 60% of patients treated with Lynparza experienced tumor shrinkage. OlympiAD enrolled 302 patients with HER2-negative, BRCA-mutated metastatic breast cancer.
“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 and acting director of the Office of Hematology and Oncology Products in the 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.”
