FDA Approves Olaparib for Breast Cancer With a BRCA Gene Mutation


The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation. Of the total sample, 558 women (20%) had triple-negative breast cancer.

The study of 2,700 women found women with a mutated BRCA gene had a 97 percent chance of surviving two years after diagnosis, compared to 96.6 percent for other breast cancer patients.

Past studies have suggested 45%-90% of women with the mutation develop breast cancer during their lifetime, compared to roughly 12.5% of women developing breast cancer in their lifetime overall in the UK. While only about five percent of breast cancers are diagnosed in women younger than 40, a high proportion of deaths fall in this age category.

On Thursday, research led by the University of Southampton concluded that BRCA-mutated breast cancer is no more risky or aggressive than any other form of the disease.

In an editorial accompanying the study, Peter Fasching, MD, of the Friedrich Alexander University Erlangen-Nuremberg in Germany, observed that while 338 patients in the POSH cohort had a BRCA1 or BRCA2 mutation, only 54% of the mutation carriers - 182 women - had been identified through routine healthcare.

The researchers tracked the women a their treatment for more than eight years.

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Olaparib - which is also indicated for ovarian cancer - is the first poly ADP-ribose polymerase (PARP) inhibitor approved to treat breast cancer and is the first agent to be approved specifically for the treatment of breast cancer with BRCA mutations. In that period, 678 women died - 651 due to breast cancer. Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, recognizes the importance of the news: "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".

The most common adverse reactions of patients who received olaparib included: nausea, anemia, fatigue, vomiting, neutropenia, respiratory tract infection, leukopenia, diarrhea, and headache.

The study's author, Professor Diana Eccles, of the University of Southampton, said: "Women diagnosed with early breast cancer who carry a BRCA mutation are often offered double mastectomies soon after their diagnosis or chemotherapy treatment".

"Decisions about timing of additional surgery to reduce future cancer risks should take into account patient prognosis after their first cancer, and their personal preferences", she added.

The majority of women (89%) underwent chemotherapy. This surgery did not appear to improve their chances of survival at the 10-year mark, according to the findings published in The Lancet Oncology.