Breast Most cancers Gene Doesn't Increase Demise Most cancers Threat

Ivan Schwartz
January 14, 2018

The Institute of Cancer Research, London, strongly welcomes the news that olaparib has been approved by the US Food and Drug Administration (FDA) for patients with advanced breast cancer.

BRCA mutations were identified in 136 (24%) of patients with triple-negative breast cancer, and 123 of these women (90%) had a BRCA1 mutation.

Their Phase III data made the showcase round at ASCO last summer and is further enhancing the FDA's focus on drugs that can target cancers triggered by the same genetic causes.

Along with the expanded approval of Lynparza, the FDA said it has "also expanded the approval of the BRACAnalysis CDx, an approved companion diagnostic to Lynparza, to include the detection of BRCA mutations in blood samples from patients with breast cancer".

It has been dubbed the "Angelina Jolie gene", after the actress revealed she underwent preventative surgery on learning she had an up to 87% chance of developing breast cancer.

Lynparza is also approved 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 whose tumors have completely or partially responded to chemotherapy. Half had breast-conserving surgery (49%), half had a mastectomy (50%), and less than 1% had no breast surgery. This was true at 2, 5 and 10 years following diagnosis.

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The BRCA1 and BRCA2 genes usually produce molecules inside cells that help to fix DNA.

BRCA-positive breast cancer is associated with survival rates similar to those for BRCA-negative cancer in young women after treatment, according to a large, ongoing, prospective study in the United Kingdom.

When it's functioning properly, BRCA actually helps fix damaged cellular DNA and prevent tumors, but when BRCA1 and BRCA2 go awry they instead encourage breast cancers. In the trial, olaparib significantly prolonged progression-free survival (PFS) compared with chemotherapy, and reduced the risk of disease progression or death by 42% (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.43-0.80; P = 0.0009).

The most frequently reported adverse events for olaparib included anemia, neutropenia, leukopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, dysgeusia, respiratory tract infections, nasopharyngitis, and arthralgia/myalgia. Because Lynparza can harm a developing fetus, women are advised to use contraception while on the drug.

"Women diagnosed with early breast cancer who carry a BRCA mutation are often offered double mastectomies soon after their diagnosis or chemotherapy treatment" compared to non-mutation carriers, study co-author Diana Eccles of the University of Southampton said in a statement.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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