AstraZeneca Receives FDA Approval for Breast Cancer Treatment


"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.

Women under the age of 40 with breast cancer have the same chances of survival whether or not they've been diagnosed with a BRCA gene mutation, new research suggests.

The study found that there was no difference in overall survival two, five or 10 years after diagnosis for women with and without a BRCA mutation. This can lead to the likelihood that the cells develop additional genetic alterations, potentially resulting in cancer.

The medication to target the gene is the first in a fairly new class of medicines for ovarian cancer called PARP inhibitors to also win approval for treating breast cancer.

Eccles, MD, University of Southampton and University Hospital Southampton NHS Foundation Trust, United Kingdom, and colleagues looked at survival following treatment for the initial breast cancer diagnosed only.

BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development.

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.

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The team tracked the women's medical records for an average period of just over eight years, and found that 651 of 678 total deaths were due to breast cancer.

The BRCA1 or BRCA2 gene mutations were dubbed the 'Angelina Jolie gene' after the actress underwent preventative surgery when she discovered she had an up to 87 percent chance of developing breast cancer.

"The trial measured the length of time the tumors did not have significant growth after treatment [progression-free survival]", the agency explained.

Common side effects of Lynparza include low levels of red blood cells (anemia), low levels of certain white blood cells (neutropenia, leukopenia), nausea, fatigue, vomiting, common cold (nasopharyngitis), respiratory tract infection, influenza, diarrhea, joint pain (arthralgia/myalgia), unusual taste sensation (dysgeusia), headache, indigestion (dyspepsia), decreased appetite, constipation and inflammation and sores in the mouth (stomatitis). Because Lynparza can harm a developing fetus, women are advised to use contraception while on the drug.

Dr. Susan M. Domchek, Executive Director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania and a national leader on the OlympiAD trials, said: "Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and hard to treat".

AstraZeneca says Lynparza will cost $13,886 per month without insurance.