In the middle of December, the Food and Drug Administration (FDA) approved Trastuzumab Deruxtecane (Enhertu) in combination with Pertuzumab (Perjeta) – a targeted HER2 monoclonal antibody – for breast cancer patients with advanced unresectable or metastatic breast cancer, who had not received chemotherapy or HER2 targeted therapy as first line treatment.
Enhertu is an advanced targeted medicine composed of an antibody and a cytotoxic drug payload. The antibody binds to the HER-2 protein on the cell surface, and releases the toxic drug to destroy the cancer while sparing healthy tissue.
The approval is supported by results from a clinical trial that enrolled 1,157 patients meeting the above-mentioned criteria, who had not previously received any treatment for metastatic disease. Patients were randomly assigned to receive either Enhertu plus Pertuzumab (study group), or (among others) chemotherapy plus Herceptin and Pertuzumab (control group).
At the end of the follow-up period, the results pointed towards a significantly higher treatment efficacy among the study group patients receiving Enhertu with Pertuzumab, compared to the control group patients receiving chemotherapy plus Herceptin and Pertuzumab.
A significantly lower risk of disease progression was also observed among the study group patients, compared to the control group patients.
It is important to note that Enhertu plus Pertuzumab may cause side effects, also reflected in abnormal laboratory test results and/or heart dysfunction, thus patients receiving it require monitoring throughout treatment.