Trodelvy is a Trop-2 directed antibody-drug conjugate, indicated for previously treated patients with metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer
US-based Gilead Sciences has received the US Food and Drug Administration (FDA) approval for Trodelvy (sacituzumab govitecan-hziy) to treat a type of breast cancer in adults.
Trodelvy is an antibody-drug conjugate that targets Trop-2, a cell surface antigen highly expressed in multiple tumour types, including in the majority of breast and bladder cancers.
It is indicated for patients with metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who were previously treated in the metastatic setting.
The drug is already approved in more than 40 countries and is currently being reviewed in several countries worldwide to treat metastatic triple-negative breast cancer (TNBC).
Trodelvy is previously approved in the US and validated in Europe to treat patients with HR+/HER2- metastatic breast cancer.
National Comprehensive Cancer Network (NCCN) recommended Trodelvy as a preferred treatment for metastatic HR+/HER2- breast cancer, said the company.
Gilead Sciences chairman and chief executive officer 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.”
The FDA approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study.
TROPiCS-02 is a global, multicentre, open-label, Phase 3 study that evaluated Trodelvy compared with chemotherapy, including eribulin, capecitabine, gemcitabine, or vinorelbine.
It enrolled in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy.
In the Phase 3 study, Trodelvy showed a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months compared to rival single-agent chemotherapy.
The drug showed a 34% reduction in risk of disease progression or death, and significantly improved additional secondary endpoint measures.
The study also showed a safety profile that was consistent with prior studies of Trodelvy, with no new safety signals observed.
Diarrhoea, febrile neutropenia, neutropenia, abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting include the most serious adverse reactions in TROPiCS-02.
TROPiCS-02 study principal investigator Hope S Rugo said: “Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options.
“Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies.
“This approval is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than three months with a quality-of-life benefit for these women is exceptional.”