New Breast Cancer Rx Gets Green Light

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat breast cancer.

This new approval is called Enhertu (fam-trastuzumab deruxtecan-nxki).

The FDA approved Enhertu to treat adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed with surgery or has spread to other parts of the body.

HER2-positive breast cancer is aggressive and accounts for an estimated 20 percent of breast cancers, according to the FDA.

Enhertu is meant for adults who have already tried at least two treatments that have targeted HER2. This medication is injected into the vein by your health care provider. It is to be given every three weeks.

“There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of Herceptin (trastuzumab) in 1998,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, in a press release. “The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies.”

Common side effects of Enhertu may include nausea, feeling very tired, vomiting, hair loss, constipation and reduced appetite. This medication comes with a boxed warning (the strongest type of drug warning) regarding a risk of conditions that can lead to scarring and inflammation of lung tissue. Other potentially serious side effects include changes in blood cell counts and heart problems.

This drug may also harm unborn babies. For both men and women, effective birth control is recommended while taking this medication.

The FDA granted approval of this medication to Daiichi Sankyo.

Written by Anyssa Garza, PharmD, BCMAS