(WKBN) – The U.S. Food and Drug Administration gave approval Friday to a cancer-fighting treatment that targets a certain type of breast cancer.
Enhertu, an IV infusion for the treatment of patients with breast cancer that is unable to be removed or has moved to other parts of the body (HER2-low breast cancer), was approved.
This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.
It’s estimated that 287,850 new cases of female breast cancer will be diagnosed in 2022 in the U.S. Approximately 80-85% of those new cases were previously considered to be HER2-negative subtype, which means the tumors do not make too many copies of the HER2 protein.
Of that proportion of breast cancer diagnoses, about 60% of patients previously classified as having HER2-negative subtype can now be considered as HER2-low.
Prior to Friday’s approval, HER2-low patients received chemotherapy.
“Having therapies that are tailored to each patient’s cancer and subtype is a priority to ensure access to safe and innovative treatments,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center for Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The development is part of the Biden Administration’s reignition of the Cancer Moonshot program, aimed at reducing the death rate from cancer by at least 50 percent over the next 25 years and improving the lives of those who are living with cancer and their families.
Patients with HER2-low breast cancer are eligible for Enhertu if they have received a prior chemotherapy in the metastatic setting, or their cancer returned during, or within 6 months of completing, adjuvant chemotherapy.T