The US Food and Drug Administration (FDA) has for 鈥� 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鈥�) 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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDatachairman and CEO Daniel O’Day said: 鈥淲e 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.
鈥淲e thank the physicians, patients and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.鈥�
Colitis, neutropenic colitis, diarrhoea, vomiting, neutropenia, , pneumonia, and abdominal pain are the most frequent serious adverse reactions observed in the TROPiCS-02 study.
