(RxWiki News) The US Food and Drug Administration (FDA) approves a new breast cancer treatment.
This approval is for Enhertu (fam-trastuzumab-deruxtecan-nxki).
It is approved to treat those with HER2-low breast cancer
- that is unable to be removed and
- has spread to other parts of the body
HER2-low breast cancer is a new subtype of breast cancer. In other words, a subset of HER2-negative breast cancer.
According to the FDA, HER2-low breast cancer is classified as having some HER2 proteins on the cell surface, but does have enough to be classified as HER2-positive.
Those with HER2-low patients received endocrine therapy or chemotherapy — until now.
Enhertu offers a new option that is given into the vein.
The approval is a result of the results from a clinical trial that included over 550 patients.
The most common adverse reactions seen in the clinical trial were
- decreased appetite
- loss of hair
- muscle pain and
There is a boxed warning with this medication which is for the risk of interstitial lung disease and harm to an unborn baby.
This approval is granted to Daiichi Sankyo.