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FDA approves Lynparza as first PARP inhibitor breast cancer treatment

Lynparza (olaparib tablets) is the first poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with breast cancer whose tumors have a specific inherited genetic mutation. Lynparza is already approved in the United States as a treatment for a number of other cancers, including ovarian, fallopian tube, and peritoneal cancers. However, the US Food and Drug Administration (FDA) has expanded its approved used to include patients with metastatic breast cancer who have a BRCA gene mutation. 

Breast cancer is the most common form of cancer in women. More than 230,000 women and 40,000 men are diagnosed with the condition each year, according to the latest US Cancer Statistics Working Group report. It occurs when cells in the breast grow abnormally, forming a benign or malignant tumor. Treatment options include chemotherapy using drugs such as Rheumatrex (methotrexate), radiation therapy, or surgery. In postmenopausal women with breast cancer, physicians may use cytostatic aromatase inhibitors to stop or slow the growth of cancer cells.  

What is Lynparza?

The FDA's decision to approve the AstraZeneca and Myriad Genetics Laboratories drug Lynparza provides further treatment options for patients with breast cancer. The medication is a PARP inhibitor, which works by blocking an enzyme responsible for cell repair. This diminishes the likelihood that cancer cells with damaged BRCA genes will be repaired, encouraging a slowing or stopping of tumor growth. Normally, BRCA genes are involved in the repair of DNA and help the body prevent the tumors developing, but mutations may lead to breast cancer and other cancers. 

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

Lynparza's efficacy as a breast cancer treatment was demonstrated in a randomized clinical trial of 302 people with HER-2 negative metastatic breast cancer with a germline BRCA mutation. Median progression-free survival for patients taking Lynparza was seven months - nearly three months more than patients whose treatment was limited to chemotherapy. The application was granted Priority Review by the FDA. 

What are the side effects? 

Common side effects of Lynparza include anemia (low levels of red blood cells), low levels of certain white blood cells, nausea, vomiting, fatigue, common cold, influenza, respiratory tract infection, diarrhea, joint pain, unusual taste sensations, headaches, indigestion, increased appetite, constipation, and inflammation and sores in the mouth. 

More severe side effects of the drug include the development of certain bone marrow or blood cancers and inflammation in the lungs. Lynparza may also harm developing fetuses and women should not breastfeed while taking this medication due to the risk of harm to a newborn baby. 

Last month, the FDA granted regular approval to another breast cancer treatment, announcing on December 20th 2017 that  patients with HER2-positive early breast cancer at a high risk of reoccurrence would have another treatment open to them in the form of pertuzumab in combination with trastuzumab and chemotherapy. 

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