FDA approves drug to treat breast cancer in patients with inherited genetic mutation

The U.S. Food and Drug Administration (FDA) approved the expanded use of Lynparza (olaparib tablets) for patients who have tumors with the inherited BCRA genetic mutation. This is the first poly ADP-ribose polymerase inhibitor utilized as treatment for those who have the 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,” Richard Pazdur, MD, 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, said in an announcement. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”

Lynparza, made by AstraZeneca Pharmaceuticals, was FDA-approved earlier in 2014 for treatment of certain patients with ovarian cancer who received three or more treatments of chemotherapy. It has also been used as a maintenance treatment therapy for patients who exhibit recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have partially or completely responded to chemotherapy.

AstraZeneca estimates that Lynparza is slated to cost $13,886 without insurance.

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As a senior news writer for TriMed, Subrata covers cardiology, clinical innovation and healthcare business. She has a master’s degree in communication management and 12 years of experience in journalism and public relations.

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