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FDA Approval For First Drug To Treat Inherited Breast Cancer

1 year, 6 months ago

1892  0
Posted on Feb 06, 2018, 11 a.m.

The FDA has expanded the approved use of Lynparza olaparib tablets to be included in the treatment of cancer patients with certain types of breast cancer that have metastasized and the tumors have a specific inherited germline genetic mutation. Lynparza olaparib tablets are the first drug in its PARP inhibitor class to be approved to be used in the treatment of breast cancer, additionally it is the first time that any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation. Patients are to be selected for treatment with Lynparza based on an FDA approved genetic test which is called the BRACAnalysis CDx.

The FDA has expanded the approved use of Lynparza olaparib tablets to be included in the treatment of cancer patients with certain types of breast cancer that have metastasized and the tumors have a specific inherited germline genetic mutation. Lynparza olaparib tablets are the first drug in its PARP inhibitor class to be approved to be used in the treatment of breast cancer, additionally it is the first time that any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation. Patients are to be selected for treatment with Lynparza based on an FDA approved genetic test which is called the BRACAnalysis CDx.

 

This class of drugs has been used in the treatment of advanced BRCA mutated ovarian cancer and has shown efficacy in the use of treatment of certain types of BRCA mutated breast cancers says M.D Richard Pazdur.

 

 It is estimated by the National Cancer Institute that approximately 252, 710 women will become diagnosed with breast cancer this year and another 40,610 women will unfortunately die of the disease. Approximately 10% of patients with and type of breast cancer, and 25% of patients with hereditary breast cancers have BRCA mutations. BRCA genes will normally work to prevent the development of tumors and are involved with repairing damaged DNA, but these mutations may lead to the development of certain cancers which include breast cancers.

 

Lynparza is a poly ADP-ribose polymerase inhibitor that blocks an enzyme that is involved in repairing damaged DNA. Blocking this enzyme the DNA inside of the cancerous cells with damaged BRCA genes may be less likely to be repaired which leads to cell death and possibly a slow down or even stoppage of tumor growth. Lynparza was originally approved by the FDA for therapeutic use in 2014 for the treatment of certain patients with ovarian cancer and is now approved for use in the treatment of patients who have previously been treated with chemotherapy with germline breast cancer susceptibility gene mutated human epidermal growth factor receptor 2 negative metastatic breast cancer. Patients with hormone receptor positive breast cancer should have been treated with a prior hormonal endocrine therapy or be considered inappropriate for endocrine treatment.

 

The FDA has also expanded the approval of the BRACAnalysis CDx an approved companion diagnostic to Lynparza to include the detection of BRCA mutations in blood samples from patients with breast cancer. The efficacy and safety of Lynparza in the treatment of breast cancer was based on a randomized clinical trial of 302 patients diagnosed with HER2 negative metastatic breast cancer with a germline BRCA mutation. The study measured how long that the tumors went without showing any significant growth after receiving treatment. The study findings were that 7 months was the median of progression free survival for patients taking Lynparza, it is only 4.2 months for patients using chemotherapy only.

Lynparza can have severe side effects which include the development of certain bone marrow or blood cancers and inflammation in the lungs, it can cause harm to a developing fetus, women should not breastfeed as it could cause harm to a newborn baby.

 

Lynparza is also approved for the maintenance treatments of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have partially or completely responded to chemotherapy, and for the treatment of patients with BRCA mutated advanced ovarian cancer who have already received at least 3 or more chemotherapy treatments.

 

Sources include:

 Note: Content may be edited for style and length.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592347.htm

 

 

 

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