(Adds details on the drug’s label)
Dec 16 (Reuters) - MacroGenics Inc said on Wednesday the U.S. Food and Drug Administration (FDA) had approved its drug Margenza in combination with chemotherapy for the treatment of an advanced type of breast cancer in patients who failed two or more prior therapies.
The cancer drug developer said it was expecting to launch the drug, the first to be approved from its pipeline, in March.
The approval is based on results of a late-stage study, which showed that a combination of Margenza and chemotherapy caused significant reduction in the risk of disease progression or death compared with Roche Holding AG’s Herceptin plus chemotherapy, the company said.
The label for Margenza carries a boxed warning, FDA’s harshest, flagging the risk of embryo-fetal harm when used during pregnancy.
The FDA also warns of risk for left ventricular dysfunction, a condition which can lead to heart failure.
The company said it has eight other product candidates currently in clinical development.
Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D’Silva