FDA grants approval to Gilead Sciences’ breast cancer therapy

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 that is attached to a 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 a minimum one of them for metastatic disease.

The FDA approval is based on the data obtained from global, multicentre, open-label Phase III TROPiCS-02 study, which was 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 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, diarrhea, vomiting, neutropenia, febrile neutropenia, pneumonia, and abdominal pain are the most frequent serious adverse reactions observed in TROPiCS-02 study.