On Friday, the U.S. Food and Drug Administration (FDA) announced accelerated approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of breast cancer.
Enhertu has been approved for treating HER2-postive breast cancer that is unable to be removed surgically or metastasized. It has also been approved for patients with HER2-postive breast cancer who have not responded to two or more anti-HER2-based treatments.
Enhertu targets the changes in HER2 that help the tumor to grow, divide and spread. The drug is a kind of topoisomerise inhibitor that has been found toxic to cancer cells.
Dr. Richard Pazdur said, “There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of Herceptin (trastuzumab) in 1998.”
“The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” added Dr. Pazdur. “Drug development in the area of targeted therapies builds on our scientific understanding of malignant diseases not only in breast cancer, but in multiple other diseases.”
Dr. Pazdur is the acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence.
The FDA approved Enhertu based on the findings of a clinical trial conducted on 184 female patients with HER2-positive breast cancer that was not able to be removed surgically or metastatic, and those who had received two or more anti-HER2 treatments.
Participants received Enhertu every three weeks and the tumor imagining was obtained every six weeks. The trial researchers found an overall drug response rate of 60.3 percent, with a certain amount of tumor shrinkage within 15 months.
Enhertu, developed by Daiichi Sankyo, includes a Boxed Warning that advises clinicians and patients about the potential risk of lung disease and embryo-fetal toxicity. Also, the FDA said medical providers should look for symptoms such a breathlessness, cough and fever. Some of the most common side effects of Enhertu include nausea, vomiting, hair loss, constipation, fatigue, loss of appetite, anemia, diarrhea, and cough.
