The European Medicines Agency has approved a drug that has been used in the United States to help treat breast cancer, giving a private oncologist more options for treatment.
The AstraZeneca drug Enhertu was approved for use by the EMA’s Committee for Medicinal Products for Human Use (CHMP) after the results of a Phase III clinical trial suggested it reduce the progression of the disease or death by as much as half compared to chemotherapy.
It has been approved as a single therapy for treating metastatic breast cancer that cannot be removed with surgery for people who have just received or are in the process of receiving chemotherapy treatment, particularly for those diagnosed with HER2-low cancer.
The term HER2-Low refers to low amounts of human epidermal growth factor receptor 2 proteins (HER2), that ordinarily help to control breast cell and tissue growth and maintain their health.
Some breast cancers (up to 20 per cent) have very high levels of HER2, which makes them aggressively divide and grow, and can be treated using targeted therapies that reduce the level of HER2 such as trastuzumab, a drug approved in 1998.
However, there are other tumours that have low levels of HER2, which cannot be targeted with those specific drugs, but thanks to clinical trials such as DESTINY-Breast04, have a much-improved chance of survival.
Enhertu has also been approved for use in treating gastric cancer, and two other cancer medications have also received marketing authorisation in the EU for advanced-stage lung and liver cancers.
A combination treatment using the drugs Imfinzi and Imjudo has received positive opinions as the result of a pair of Phase III clinical trials, which helps to offset the disappointment AstraZeneca felt when the latter struggled to be effective as a single-drug therapy.
However, more options for patients with cancer are always an important step, as it allows for alternatives to be used if a first-line treatment proves unsuitable.