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FDA Approves Two New Treatments For Metastatic TNBC

FDA Approves Two New Treatments For Metastatic TNBC

The drugs are the first antibody-drug conjugates approved to treat this aggressive form of breast cancer as a first-line treatment.
Written by |Reviewed by |Updated on July 29, 2026
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People with metastatic triple-negative breast cancer (TNBC) have two new first-line treatment options thanks to recent approvals by the US Food and Drug Administration (FDA). 

The FDA approved Datroway (chemical name: datopotamab deruxtecan) in May and Trodelvy (chemical name: sacituzumab govitecan-hziy) in June to be used as first-line treatments for metastatic TNBC. The drugs are the first antibody-drug conjugates (ADCs) approved for this use. ADCs, sometimes called “smart chemo,” deliver chemotherapy directly to cancer cells, unlike regular chemo, which harms both healthy and cancerous cells.  

People with metastatic TNBC are often treated with chemotherapy and the immunotherapy Keytruda, if their tumor is PD-L1-positive (it has a lot of PD-L1 proteins on it). But only around 30% of metastatic TNBC tumors are PD-L1-positive, leaving chemo as the only option for many people. 

These approvals offer new treatment options outside of chemo. Trodelvy and Datroway are both approved for people with metastatic TNBC who aren’t eligible for Keytruda. Trodelvy can also be used in combination with Keytruda for people with PD-L1-positive metastatic TNBC. 

Both drugs outperformed chemotherapy alone in clinical trials. After about one year of treatment, both drugs reduced the risk of disease progression by around 40% in people who were ineligible for Keytruda. Trodelvy plus Keytruda reduced the risk of disease progression by 35% compared to chemotherapy alone for people with PD-L1-positive metastatic TNBC. 

Both Datroway and Trodelvy target a protein called Trop-2, which is found on about 80% of breast cancer cells. They deliver a small amount of chemotherapy directly to the cancer cells. The difference is the type of chemotherapy they carry: Datroway delivers a drug called DXd, while Trodelvy delivers one called SN-38. 

Scientists have been searching for alternatives to chemo-only treatment for over 20 years, Ricki Fairley, cofounder of TOUCH, The Black Breast Cancer Alliance, said in a press release about Trodelvy. “This approval represents meaningful progress for the families impacted by this disease.”