Trodelvy FDA Approved: May Improve MTNBC In Black Women

A groundbreaking new treatment is giving fresh hope to people diagnosed with one of the most aggressive forms of breast cancer. The U.S. Food and Drug Administration (FDA) has approved Trodelvy, a chemotherapy medicine that can now be used as a first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). The milestone marks a major advancement for patients facing a disease that has long had limited treatment options, particularly Black women, who are diagnosed with triple-negative breast cancer at disproportionately higher rates, often at younger ages and with more aggressive rates of the disease.

The approval, announced by Gilead Sciences on June 24, expands how Trodelvy (sacituzumab govitecan-hziy) can be used to treat certain patients. Trodelvy is a targeted cancer therapy that delivers chemotherapy directly to cancer cells. Under the expanded approval, it can now be used on its own for patients who are not good candidates for immunotherapy, or in combination with the immunotherapy drug Keytruda for patients whose tumors test positive for the PD-L1 protein using an FDA-approved test. This gives doctors greater flexibility to tailor treatment based on a patient’s health and the characteristics of their cancer.

What Is Metastatic Triple-Negative Breast Cancer (mTNBC)?

Triple-negative breast cancer (TNBC) is one of the most difficult forms of breast cancer to treat because the cancer cells lack estrogen receptors, progesterone receptors, and excess HER2 protein, the three targets that many standard breast cancer therapies rely on, according to BreastCancer.Org.

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When TNBC becomes metastatic, it means the cancer has spread beyond the breast to other parts of the body, including the bones, lungs, liver, or brain. Because hormone therapies and HER2-targeted drugs are ineffective against TNBC, patients have historically had fewer treatment options, and the disease is often considered more aggressive due to its tendency to grow and spread more quickly.

Now, researchers believe Trodelvy could help change that outlook.

Trodelvy approved by the FDA: How does it work?

Trodelvy is a targeted cancer treatment designed to deliver chemotherapy directly to cancer cells while limiting damage to healthy tissue. It works by recognizing a protein called Trop-2, which is found in high amounts on the surface of more than 90% of breast and lung cancer cells.

Once Trodelvy attaches to a cancer cell, it releases a powerful chemotherapy drug directly inside the tumor. Some of the medicine also spreads into the surrounding tumor tissue, helping destroy nearby cancer cells that may not have as much Trop-2. This targeted approach allows Trodelvy to attack cancer more precisely than traditional chemotherapy, while also reaching cancer cells that might otherwise escape treatment.

Trodelvy was FDA approved after positive trial results.

Trodelvy’s FDA approval was supported by results from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 clinical trials, which showed that Trodelvy-based treatments significantly improved outcomes for patients with mTNBC.

Among patients whose tumors were not eligible for PD-L1-targeted immunotherapy, Trodelvy reduced the risk of disease progression or death by 38% compared with chemotherapy alone. For patients with PD-L1-positive tumors, combining Trodelvy with Keytruda reduced that risk by 35% compared with Keytruda plus chemotherapy.

PD-L1 (Programmed Death-Ligand 1) is a protein that acts as a “brake” for the immune system, according to the National Cancer Institute. Under normal circumstances, it helps prevent healthy tissues from being attacked by the body’s own immune cells. However, many cancer cells exploit this pathway by displaying PD-L1 on their surface, allowing them to evade detection by T cells. 

Immunotherapy drugs such as Keytruda block the interaction between PD-L1 and its receptor, PD-1, effectively releasing the immune system’s “brakes” and enabling T cells to recognize and destroy cancer cells. The study found that adding Trodelvy to Keytruda further enhanced this benefit, leading to significantly longer progression-free survival than treatment with Keytruda and chemotherapy alone.

For breast cancer advocate and TNBC survivor Ricki Fairley, Trodelvy offers hope for Black Women facing the disease. 

For advocates in the breast cancer community, especially those working to address racial disparities in care, the FDA approval represents more than another drug, it offers renewed hope.

Ricki Fairley, Co-Founder and CEO of TOUCH, The Black Breast Cancer Alliance, knows the devastating reality of the disease firsthand. Diagnosed with triple-negative breast cancer in 2011 after it had already spread to her chest wall, Fairley has since become one of the nation’s leading voices for Black women battling breast cancer.

According to the advocate, Black women are diagnosed with triple-negative breast cancer at approximately 2.3 times the rate of white women and experience a 42% higher mortality rate, making advances like Trodelvy especially significant for a community that has long faced poorer outcomes.

“For patients with metastatic TNBC, a new first-line treatment option offers optimism to a community with historically few choices,” said Fairley in a press release. “TNBC disproportionately affects younger women – many in the prime of their lives – and often leads to poorer outcomes. Because so many patients may never receive subsequent lines of therapy, the ability to start with a promising option like Trodelvy with or without Keytruda is critical. We have sought additional alternatives to chemotherapy-containing regimens in the first-line metastatic setting since TNBC was classified as a disease more than 20 years ago. As such, this approval represents meaningful progress for the families impacted by this disease.”

Following the positive ASCENT-03 and ASCENT-04 trial results, the National Comprehensive Cancer Network (NCCN) now recommends Trodelvy, with or without Keytruda, as a Category 1 preferred first-line treatment option for mTNBC, regardless of PD-L1 status. Trodelvy also continues to hold Category 1 recommendations for second-line metastatic TNBC and for certain patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

Doctors are also becoming increasingly familiar with the therapy. More than 75,000 breast cancer patients across more than 60 countries have been treated with Trodelvy over the past six years. It remains the only Trop-2-directed antibody-drug conjugate to demonstrate meaningful overall survival benefits in both second-line or late stage mTNBC and previously treated HR+/HER2-negative metastatic breast cancer, the most common subtype of breast cancer, further demonstrating its place as one of the most promising advances in breast cancer treatment today.

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