At the beginning of February, the Food and Drug Administration (FDA) approved Sacituzumab govitecan (Trodelvy) for breast cancer patients with unresectable locally advanced or metastatic disease, whose tumors are hormone receptor-positive HER2-negative, and who have been treated with both endocrine therapy and chemotherapy*.
Trodelvy is a targeted (biological) therapy called an anti-drug conjugate. It is made up of two components: the targeted drug which has the ability to bind itself to cancer cells, and the attached chemotherapy drug that as a result is delivered directly into these cancer cells.
The approval is supported by results from a clinical trial in which 543 patients meeting the abovementioned criteria, were randomly assigned to receive either Trodelvy (study group), or chemotherapy (control group).
At the end of the follow-up period, results pointed towards a significantly lower risk of disease progression among the study group patients, compared to the control group patients.
Moreover, a significantly lower death rate was observed among patients in the study group, compared to those in the control group.
Among the common adverse events in patients receiving Trodelvy were low blood count, diarrhea or constipation, fatigue, nausea and alopecia.
Trodelvy provides an additional effective treatment for locally advanced or metastatic breast cancer patients, whose illness has regressed after endocrine therapy and chemotherapy.
*Trodelvy has already been approved for the treatment of such patients with triple negative breast cancer.