FDA Approved a New drug for treatment of breast cancer.the United States of America has approved the use of Lynparza (olaparib) in the treatment of breast cancer.The Food and Drug Administration approved AstraZeneca PLC’s Lynparza for patients with inherited BRCA gene mutations who have undergone chemotherapy, the FDA said in a statement. The approval was announced on Friday.
According to a report by Breast Cancer News, the drug will be used in the treatment of metastatic breast cancer, which is cancer that has spread beyond the breast to other organs in the body.Lynparza is said to increase the time patients live without their cancer progressing like it would in chemotherapy.
The drug has been on the market since 2014 for ovarian cancer, and recently has been approved to treat breast cancer. It is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation.
“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 Dr. Richard Pazdur, director of the FDA’s 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. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”
Approximately 20 percent to 25 percent of patients with hereditary breast cancers and up to 10 percent of patients with any type of breast cancer have a BRCA mutation. BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including breast cancers, the FDA statement said.
The fast-tracked approval of Lynparza was based on a trial of 302 women with metastatic breast cancer and a BRCA gene mutation. The drug delayed the spread of the cancer for seven months as opposed to four months for women taking chemotherapy only, according to the FDA.
Lynparza will cost $13,886 per month without insurance, the Associated Press reported, citing AstraZeneca.
BRCA1 and BRCA2 (BReast CAncer genes 1 and 2) are the best-known genes linked to breast cancer risk. Everyone has these genes, but some people have an inherited mutation in one or both that increases the risk of breast cancer.
BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of the cell’s genetic material. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
Women who have a BRCA1/2 gene mutation have an increased risk of breast cancer.
Estimates of risk are different for BRCA1 carriers and BRCA2 carriers.
- BRCA1 carriers have a 55-65 percent chance of developing breast cancer by age 70
- BRCA2 carriers have about a 45 percent chance of developing breast cancer by age 70
Women in the general population have about a 7 percent chance of getting breast cancer by age 70 . (Lifetime risk of breast cancer, up to age 95 and older, is about 12 percent .)
This means by age 70:
- In a group of 100 women without a mutation, about 7 will get breast cancer (about 12 by age 95 or older)
- In a group of 100 women with a BRCA1/2 mutation, 45-65 will get breast cancer.