Gilead’s Trodelvy (sacituzumab govitecan) has announced that it has received approval from the US FDA for triple-negative breast cancer (TNBC). It is approved to treat adult patients with advanced or metastatic triple-negative breast cancer (TNBC), who have previously treated two or more systemic therapies, at least one treatment is indicated for metastatic disease.
The approval is based on the Phase 3 ASCENT trial; progression-free survival was increased by 57%, median PFS was increased to 4.8 months from 1.7 months with chemotherapy. The median overall survival increased to 11.8 months versus 6.9 months, representing a reduction in risk of death by 49%.
Trodelvy acts on Trop-2 receptor, protein’s high expression eventually leads to poor survival and relapse. The product has received approval in April 2020, objective response rate and duration of response in Phase ½ trial was considered for accelerated approval.
Company announced that safety approval is consistent with previous adverse events. Neutropenia, diarrhea, leukopenia, and anemia were the common adverse events reported.
Regulatory approvals were submitted for the approvals in United Kingdom, Canada, Switzerland, and Australia. European Medicines Agency validated the application of Trodelvy.