Anvisa approves new uses for triple-negative breast cancer drug

Brazil’s National Health Surveillance Agency (Anvisa) has approved new therapeutic indications for the drug Trodelvy (sacituzumab govitecan) to treat adult patients with triple-negative breast cancer (TNBC).

The approval includes two primary applications. First, the drug can be used in combination with pembrolizumab as a first-line treatment for adults with unresectable, locally advanced, or metastatic TNBC whose tumors express PD-L1. Second, it is approved as a monotherapy for first-line treatment in patients with unresectable, locally advanced, or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor treatments.

TNBC is considered an aggressive subtype of breast cancer characterized by a poor prognosis and limited therapeutic options. Trodelvy functions as an antibody-drug conjugate that targets the Trop-2 protein on the surface of cancer cells to deliver chemotherapy directly to them. The registration was published in the Official Gazette of the Union on Tuesday, the 8th.