Lynparza Approved to Treat Metastatic HER2-Negative Breast Cancer in Women With BRCA Mutations

On Jan. 12, 2018, the U.S. Food and Drug Administration approved Lynparza (chemical name: olaparib) to treat metastatic, HER2-negative breast cancer in women with a BRCA1 or BRCA2 mutation.

Read the FDA press announcement.

Most inherited cases of breast cancer are associated with two abnormal genes: BRCA1 (BReast CAncer gene one) and BRCA2 (BReast CAncer gene two). Women with a mutation in the BRCA1 or BRCA2 gene have up to an 85% risk of developing breast cancer by age 70. Their risk of ovarian cancer also is higher than average. Men with an abnormal BRCA gene have a higher risk of both breast and prostate cancer.

DNA carries genetic information in both healthy cells and cancer cells. Cells can develop DNA damage spontaneously or from exposure to specific things in the environment (too much sun, for example) that make DNA damage more likely to happen. But cells can detect and repair damage to DNA. When DNA is damaged in a healthy cell and the damage isn’t fixed, that cell can become cancerous. Mutated BRCA1 and BRCA2 genes are thought to increase the risk of breast and other cancers because these abnormal genes interfere with cells’ ability to repair damaged DNA.

The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells. Research has shown that Lynparza, which interferes with (inhibits) the PARP enzyme, makes it even harder for cancer cells with an abnormal BRCA1 or BRCA2 gene to fix DNA damage. This makes it harder for the cancer cells to survive. In other words, a PARP inhibitor makes some cancer cells less likely to survive their DNA damage.

Lynparza is a capsule taken by mouth.

Lynparza is the first PARP inhibitor approved to treat breast cancer and is the first medicine approved to specifica…

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