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giftedviz.com June 20, 2018


Breast cancer gene not linked to higher risk of death

14 January 2018, 12:30 | Rodolfo Wallace

Breast cancer gene not linked to higher risk of death

Breast cancer gene not linked to higher risk of death

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, said, "This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved beyond ovarian cancer". "This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of cancer, often across cancer types". "This is significant for breast cancer patients, as the identification of the BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease".

The study involved 2,733 British women from 127 hospitals, who had been diagnosed with the condition at the age of 40 or below. Twelve percent of the women had a BRCA mutation.

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

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

Survival rates after two years were 97 percent for women with a BRCA mutation and 96.6 percent for those without the mutation, the findings showed. 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 common adverse reactions of patients who received olaparib included: nausea, anemia, fatigue, vomiting, neutropenia, respiratory tract infection, leukopenia, diarrhea, and headache.

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Severe side effects occurred in 37 percent of Lynparza patients, compared to 51 percent of those on standard therapy.

These are offered to women with faulty genes to cut their risk of developing cancer.

Its U.S. marketing application for same indication as ZEJULA is now under FDA review with an action date of April 6.

This is the third indication approved for Lynparza in the United States, where it has been used to treat almost 4,000 advanced ovarian cancer patients.

Lynparza has been a key part of AstraZeneca CEO Pascal Soriot's case that oncology represents a big growth opportunity - badly needed after generics chewed up market niches worth billions.

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. The approval of the BRACAnalysis CDx was granted to Myriad Genetic Laboratories, Inc. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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