FDA Approves Trodelvy for HR+/HER2- Breast Cancer

The FDA has approved Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) to treat patients with locally advanced or metastatic breast cancer. It is indicated for patients who are HR+/HER2-, the most common type of breast cancer. It accounts for about 70% of all new cases. Five-year relative survival rate for these patients is 30%.

Trodelvy has also been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.The drug has a cash price of $2,419 per vial. Gilead Sciences offers patients assistance with $0 out of pocket for up to $25,000 annually.

Hope S. Rugo, M.D.

“Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options,” principal investigator Hope S. Rugo, M.D., professor of Medicine and director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, said in a press release. “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.”

The approval is based on progression-free survival and overall survival data from the phase 3 TROPiCS-02 study. Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months compared with the treatment of physician’s choice. Trodelvy also demonstrated a 34% reduction in risk of disease progression or death. Three times as many people treated with Trodelvy were progression free at one year versus those treated with chemotherapy.

The safety profile for Trodelvy was consistent with prior studies, with no new safety signals identified in this patient population.

Trodelvy is approved in more than 40 countries to treat adult patients with metastatic triple-negative breast cancer, and has been granted accelerated approval in the United States to treat patients with metastatic urothelial cancer