The FDA on Friday expanded approval for AstraZeneca Pharmaceuticals' cancer drug, Lynparza, to treat certain forms of breast cancer.
Here are three things to know.
1. The FDA first approved Lynparza to treat certain types of ovarian cancer in 2014. The drug may now be used to treat breast cancer patients with metastasized tumors that carry a specific BRCA gene mutation.
- This indication makes Lynparza the first drug in its class approved to treat breast cancer, and the first drug ever approved to treat metastatic breast cancer patients with a BRCA gene mutation.
- The FDA also expanded approval for BRACAnalysis CDx, a genetic test developed by Myriad Genetic Laboratories, to help clinicians identify patients who will benefit from treatment with Lynparza.