Trodelvy for Triple-Negative Breast Cancer Gains Full FDA Approval

The FDA has granted full approval for Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) for treating women with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior lines of therapy.

The agency initially granted Trodelvy an Accelerated Approval in April 2020 on condition that further trials be conducted to evaluate its benefit. The FDA had previously granted the drug Priority Review, Breakthrough Therapy and Fast-Track designations.

A phase 3 study in 529 patients showed Trodelvy reduced the risk of disease worsening or death by 57 percent, lengthening progression-free survival from 1.7 months to 4.8 months when compared with single-agent chemotherapy. The therapy also reduced the risk of death by 49 percent and extended overall survival from 6.9 months to 11.8 months.

Gilead Sciences acquired Morris Plains, N.J.-based Immunomedics in October 2020 for an estimated $21 billion.