Trodelvy Approved for Metastatic, Hormone Receptor-Positive Breast Cancer
On Feb. 3, 2023, the U.S. Food and Drug Administration (FDA) expanded the use of the targeted therapy Trodelvy (chemical name: sacituzumab govitecan-hziy) so it can now be used to treat unresectable locally advanced or metastatic hormone receptor-positive and hormone receptor-negative, HER2-negative breast cancer that has been previously treated with at least two other systemic treatments. If the cancer is hormone receptor-positive, it has to have been previously treated with hormonal therapy. Both women and men diagnosed with this type of breast cancer can receive Trodelvy.
Locally advanced breast cancer means the cancer has spread to tissue near the breast, but not to parts of the body away from the breast. Metastatic breast cancer means the cancer has spread to parts of the body away from the breast, such as the bones or liver.
Unresectable means the cancer can’t be removed with surgery.
Systemic treatments are treatments that affect the whole body by going through the bloodstream. Chemotherapy medicines, hormonal therapy medicines, targeted therapy medicines, and immunotherapy medicines are examples of systemic treatments.
Before this announcement, Trodelvy was approved to treat unresectable locally advanced or metastatic triple-negative breast cancer.
About Trodelvy
Trodelvy is an immune targeted therapy medicine. It is made up of:
sacituzumab, a type of molecule called a monoclonal antibody that targets the Trop-2 protein; the Trop-2 protein is found in 80% of breast cancers
SN-38, a topoisomerase I inhibitor chemotherapy; topoisomerase I inhibitors work by interfering with a cancer cell’s ability to replicate
a compound that links the sacituzumab to the SN-38
Doctors call Trodelvy an antibody-drug conjugate. The linking compound attaches (conjugates) the monoclonal antibody sacituzumab to the SN-38 chemotherapy.
The FDA’s expanded approval of Trodelvy was based on results from the TROPiCS-02 study, which found that compared with doctors’ choice of chemotherapy, Trodelvy improved both progression-free survival and overall survival in adults diagnosed with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer that had grown after the following treatments in any setting: a CDK 4/6 inhibitor, hormonal therapy, and a taxane. The cancers had been treated with at least two lines of chemotherapy in the metastatic setting.
Progression-free survival is how long people live without the cancer growing. Overall survival is how long people live, whether or not the cancer grows.
Listen to The Breastcancer.org Podcast episode featuring Dr. Hope Rugo discussing results from the TROPiCS-2 study.
Trodelvy Offers Benefits for Hormone Receptor-Positive Breast Cancer
Sep 22, 2022“What we showed in [the TROPiCS-02] analysis was that overall survival was significantly longer in patients who received sacituzumab — a very encouraging result,” Dr. Rugo told Breastcancer.org. “The median difference was 3.2 months. When we think about the percentage of patients who are alive at 12 months — that’s also to me a very important endpoint — it was 47% for chemo and 61% for sacituzumab. So that’s really important.”
What this means for you
If you’ve been diagnosed with metastatic, hormone receptor-positive, HER2-negative breast cancer that has grown during treatment with hormonal therapy, a CDK4/6 inhibitor, and chemotherapy, you may want to talk to your doctor about this study and ask if Trodelvy makes sense for you.
Learn more about Trodelvy.
— Last updated on February 24, 2023 at 2:10 PM