The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies in the metastatic setting.

A first-in-class Trop-2 directed antibody-drug conjugate, Trodelvy has been designed with a hydrolyzable linker attached to topoisomerase I inhibitor payload SN-38.

It has already received approval in over 40 countries to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) adult patients who have previously received two or more systemic therapies, with at least one of them for metastatic disease.

The FDA approval is based on the data obtained from a global, multicentre, open-label Phase III TROPiCS-02 study conducted in 543 HR+/HER2- metastatic breast cancer patients who have received prior endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease.

Trodelvy showed 3.2 months of statistically significant and clinically meaningful overall survival (OS) compared with single-agent chemotherapy and a 34% reduction in risk of disease progression or death.

Gilead Sciences chairman and CEO Daniel O’Day said: “We are pleased that Trodelvy could now provide new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer.

“We thank the physicians, patients and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.”

Colitis, neutropenic colitis, diarrhoea, vomiting, neutropenia, febrile neutropenia, pneumonia, and abdominal pain are the most frequent serious adverse reactions observed in the TROPiCS-02 study.