AstraZeneca Says FDA Oks Lynparza For Metastatic Breast Cancer

AstraZeneca Says FDA Oks Lynparza For Metastatic Breast Cancer

AstraZeneca Says FDA Oks Lynparza For Metastatic Breast Cancer

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.

In a commentary accompanying the study, Peter Fasching, from Friedrich-Alexander University Erlangen-Nuremberg in Germany, wrote: "Understanding prognosis in young patients is important because patients with BRCA mutations are at increased risk of developing specific conditions, such as secondary cancers".

The most recent indication approved for the drug is the third, making it the only PARP inhibitor regulated in metastatic breast cancer, and the only PARP inhibitor approved in more than one tumor type. Most importantly, they uncovered that there was no difference in overall survival two, five, or ten years after diagnosis for women with and without a BRCA mutation.

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.

The majority of women in the study underwent chemotherapy.

The BRCA1 and BRCA2 genes play a critical role maintaining the genetic stability of cells, and produce proteins responsible for repairing damaged DNA.

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.

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The study, published in, found 12% of 2,733 women aged 18 to 40 treated for breast cancer at 127 hospitals across the United Kingdom between 2000 and 2008 had a BRCA mutation.

'This study can reassure young women with breast cancer ... that breast conservation with radiotherapy is a safe option in the first decade after diagnosis and double mastectomy is not essential or mandatory at initial treatment.

The FDA has approved olaparib (Lynparza, AstraZeneca/Merck) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients who took the drug had an average seven months of progression-free survival, compared to 4.2 months among patients who were given only chemotherapy.

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). Women taking Lynparza should not breastfeed as it could cause harm to a newborn baby.

Note that this observational study of young (less than age 40) women with breast cancer demonstrated similar survival after diagnosis regardless of BRCA mutation status.

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

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