AstraZeneca Gets Lynparza US Approval For Breast Cancer Treatment

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The research team, led by the University of Southampton, used data from 2,733 young women in 127 United Kingdom hospitals who had been diagnosed with primary breast cancer before the age of 40. "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", said Richard Pazdur, MD, director of the FDA 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.

Women who have BRCA mutations do as well after treatment for breast cancer as other patients, British researchers reported Thursday.

Young breast cancer patients with a BRCA gene mutation have the same chances of survival after treatment as those without the mutation, a new study finds.

"This important topic needs more prospective research as preventive surgical measures might have an effect on what might be a very long life after a diagnosis of breast cancer at a young age", wrote Peter Fasching from the Friedrich-Alexander University Erlangen-Nuremberg, Germany. After 10 years, those rates were 73.4 percent and 70.1 percent, respectively.

"Our findings suggest that this surgery does not have to be immediately undertaken along with the other treatment".

"In particular, being able to give some women with triple negative breast cancer the choice to delay a risk-reducing mastectomy would allow them to take back control of a major part of their treatment and offer them more time to recover from their initial therapy".

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'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'.

The study found that there was no difference in overall survival two, five or 10 years after diagnosis for women with or without a BRCA mutation.

The BRCA mutation may be most famous for its association with Angelina Jolie, who announced she carried the BRCA1 mutation in 2013 in a New York Times opinion piece.

TESARO's PARP inhibitor ZEJULA (niraparib) was OK'd in the U.S.in March 2017 for the maintenance treatment of recurrent epithelial ovarian (and fallopian tube and primary peritoneal cancers) in patients who are in complete or partial response to platinum-based chemo regardless of their BRCA status.

The study ended in 2008, and in the last 10 years several new treatments have been released to the market.

About a third of those with the BRCA mutation had a double mastectomy to remove both breasts after being diagnosed with cancer, the same surgery Jolie went through. It is also approved in the USA for advanced ovarian cancer patients who have received at least three prior lines of chemo and maintenance treatment of ovarian cancer in patients who are in complete or partial response to platinum-based chemo, both BRCA-positive. The FDA says it is expanding approval of Lynparza (olaparib) to include use against BRCA-linked tumors that have spread outside the breast.

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