AstraZeneca Receives FDA Approval for Breast Cancer Treatment

AstraZeneca Receives FDA Approval for Breast Cancer Treatment

BRCA carriers with triple-negative breast cancer, however, may have a survival advantage over those without the mutation in the first few years after diagnosis, reported Diana M. Eccles, MD, of the University of Southampton School of Medicine, and colleagues in The Lancet Oncology.

USA regulators have approved the first drug to treat women with advanced breast cancers caused by the same flawed gene that Angelina Jolie made famous. "This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of cancer, often across cancer types".

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.

Faulty BRCA1 or BRCA2 genes are inherited and these mutations place women at a greater risk of breast and some ovarian cancers.

TESARO's PARP inhibitor ZEJULA (niraparib) was OK'd in the 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 BRCA1 and BRCA2 genes play a critical role maintaining the genetic stability of cells, and produce proteins responsible for repairing damaged DNA.

For the new study, Eccles and a team recruited 2,733 British women aged 18-40 who had been diagnosed with breast cancer between 2000 and 2008.

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She said she was now keen to understand how women fared more than 10 years after their diagnosis.

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.

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. "For the portion of the 155,000 women in the U.S. living with metastatic breast cancer who have an inherited BRCA mutation, today's news is encouraging".

The safety and effectiveness of Lynparza for women with advanced BRCA-linked breast cancers was established after a trial of more than 300 patients. Olaparib significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression by 42%.

Lynparza's most common side effects included anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, cold-like symptoms, and respiratory tract infections.

AstraZeneca Plc (AZN.L, AZN) and Merck & Co., Inc., said that the US Food and Drug Administration has approved Lynparza (olaparib), 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.

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