FDA Approves Trodelvy Alone or With Keytruda for First-Line Triple-Negative Breast Cancer

The Food and Drug Administration (FDA) on June 24, 2026, approved Trodelvy (sacituzumab govitecan-hziy) for two uses in adults with triple-negative breast cancer (TNBC), a type of breast cancer that lacks three common receptors, making it harder to treat with hormone therapies. Trodelvy is manufactured by Gilead Sciences, Inc.

The first approval covers Trodelvy on its own as an initial treatment for adults with triple-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body, in patients who are not candidates for immunotherapy. The second approval covers Trodelvy used together with Keytruda (pembrolizumab) or Keytruda Qlex as an initial treatment for patients whose tumors test positive for a protein called PD-L1, as confirmed by an FDA-authorized test. Keytruda and Keytruda Qlex are manufactured by Merck & Co., Inc.

The ASCENT-03 Trial

The approval of Trodelvy on its own was based on the ASCENT-03 trial, a clinical study that enrolled 558 patients with advanced triple-negative breast cancer who had not yet received any systemic treatment — meaning medication that travels through the bloodstream to reach cancer cells throughout the body — for their advanced disease, and who were not eligible for immunotherapy.

Patients were randomly divided into two equal groups. One group received Trodelvy. The other received standard chemotherapy chosen by their doctor, which could include nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin.

The ASCENT-04/KEYNOTE-D19 Trial

The approval of Trodelvy in combination with Keytruda was based on the ASCENT-04/KEYNOTE-D19 trial, a clinical study that enrolled 443 patients with advanced triple-negative breast cancer who had not yet received systemic treatment for their advanced disease and whose tumors tested positive for PD-L1.

Patients were randomly divided into two equal groups. One group received Trodelvy plus Keytruda. The other received standard chemotherapy plus Keytruda.

Progression-Free Survival Results

The main goal of both trials was to measure progression-free survival — how long patients lived without their cancer getting worse.

In ASCENT-03, patients who received Trodelvy went an average of 9.7 months without their cancer worsening, compared with 6.9 months for patients on standard chemotherapy. That represents a 38% reduction in the risk of cancer progression or death. Additionally, 50% of patients on Trodelvy saw their tumors shrink or disappear, compared with 47% on chemotherapy.

In ASCENT-04/KEYNOTE-D19, patients who received Trodelvy plus Keytruda went an average of 11.2 months without their cancer worsening, compared with 7.8 months for patients on chemotherapy plus Keytruda. That represents a 35% reduction in the risk of cancer progression or death. Additionally, 61% of patients on Trodelvy plus Keytruda saw their tumors shrink or disappear, compared with 55% on chemotherapy plus Keytruda. Data on how long patients lived overall were not yet available at the time of analysis in either trial.

Recommended Dose and Administration

The recommended dose of Trodelvy is 10 milligrams per kilogram of body weight, given through an IV infusion on days 1 and 8 of each 21-day treatment cycle, either alone or in combination with Keytruda. Treatment continues until the cancer progresses or side effects become too difficult to manage. A doctor will determine the appropriate dosing schedule for Keytruda or Keytruda Qlex.

Key Side Effects and Warnings

Trodelvy carries a boxed warning — the FDA's most serious category of warning — for two potentially severe side effects: diarrhea and low white blood cell counts (neutropenia), which can increase the risk of serious infection. Other important warnings include allergic or infusion-related reactions, nausea and vomiting, higher risk in patients whose bodies process the drug more slowly due to a genetic variation in the UGT1A1 enzyme, and potential harm to an unborn baby. Patients who are pregnant or may become pregnant should talk with their doctor about these risks before starting treatment.

Keytruda carries warnings for immune-related side effects — meaning the immune system may attack healthy organs — as well as infusion reactions, complications following stem cell transplant, and potential harm to an unborn baby.

This approval was reviewed under Project Orbis, an FDA initiative that allows cancer drug approvals to be reviewed simultaneously by regulatory agencies in multiple countries, including Australia, Israel, Brazil, Canada, and Switzerland.

References

1. "FDA Approves Sacituzumab Govitecan-hziy (Trodelvy) as Monotherapy and in Combination With Pembrolizumab for First-Line Treatment of Triple-Negative Breast Cancer." U.S. Food and Drug Administration. June 24, 2026.