(RxWiki News) The US Food and Drug Administration (FDA) has approved a new breast cancer medication.
This new approval is called Trodelvy (sacituzumab govitecan-hziy). The FDA approved it to treat triple-negative breast cancer in adults.
This medication is approved for those:
- Whose cancer has spread to other parts of the body
- Who have been given two or more treatments in the past
Sacituzumab govitecan-hziy is available as an injection and is to be administered into a vein by a health care professional.
An estimated 2 of every 10 breast cancer diagnoses are triple-negative. Triple-negative breast cancer is cancer that tests negative for the following:
- Estrogen receptors
- Progesterone receptors
- Human epidermal growth factor receptor 2 (HER2) protein
This type of breast cancer has limited treatment options because it can't be treated with medications that target HER2 or with hormonal therapy medications.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options," said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the agency's Office of Oncologic Diseases, in a press release. "Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy."
Common side effects of Trodelvy included nausea, vomiting, diarrhea/constipation, feeling tired, hair loss, stomach pain and changes in blood cell counts. This medication also carries a boxed warning (the strongest type of warning) for the risk of severe neutropenia (low levels of white blood cells) and severe diarrhea. Your health care provider will monitor your blood cell counts and watch for diarrhea, adjusting treatment as needed.
This medication is not to be taken during pregnancy because it may harm your unborn baby.
This medication's approval was granted to Immunomedics, Inc.
Speak with your health care provider if you have any questions.