New treatment options have emerged for patients with triple-negative breast cancer, one of the most aggressive and difficult-to-treat breast cancer subtypes. On Wednesday, the U.S. Food and Drug Administration granted approval to Gilead Sciences’ drug Trodelvy for use as a first-line treatment in patients newly diagnosed with advanced triple-negative breast cancer. This marks the second recent approval for a drug in this category after AstraZeneca and Daiichi Sankyo’s Datroway received FDA clearance last month for similar patients.

Both Trodelvy and Datroway belong to a class of therapies called antibody-drug conjugates. These treatments combine an antibody that targets a protein commonly found on triple-negative breast cancer cells with a chemotherapy agent, delivering a concentrated dose directly to tumors. This targeted approach aims to minimize damage to healthy tissue compared with conventional chemotherapy.

Clinical trials for both drugs demonstrated roughly a 40% reduction in the risk of disease progression compared with chemotherapy alone. Trodelvy’s approval was based on two studies that assessed how long the medication could delay tumor growth, although data on overall survival benefits remain insufficient. In patients ineligible for immunotherapy, Trodelvy reduced the risk of progression or death by 38%. For about 30% of patients who are candidates for immunotherapy, a combination of Trodelvy and Merck’s Keytruda showed a 35% reduction in progression risk.

Datroway’s clinical trial reported a 43% decrease in risk of progression and extended median survival by five months compared with chemotherapy. AstraZeneca has not tested Datroway in combination with immunotherapy for triple-negative breast cancer. Because the two drugs have not been compared directly, physicians cannot definitively state which treatment is more effective.

Triple-negative breast cancer accounts for approximately 48,000 new diagnoses annually in the United States and disproportionately affects younger women, as well as Black and Latina patients. The cancer typically progresses rapidly, with median survival under two years for advanced cases. Its aggressive nature underscores the importance of effective first-line therapies, as nearly half of patients do not move on to secondary treatments.

Gilead’s chief medical officer, Dietmar Berger, highlighted the critical role of potent drugs in early treatment. Meanwhile, analysts project peak annual breast cancer sales of $714 million for Datroway and over $2.4 billion for Trodelvy.

Among patients experiencing the impact of these new therapies is Terri Childers, a 63-year-old from Abilene, Texas, who was diagnosed with metastatic triple-negative breast cancer in 2023. After enrolling in a Gilead clinical trial and starting Trodelvy combined with Keytruda, her tumors have shrunk, enabling her to continue a semblance of normal life despite ongoing treatment.

Both Gilead and AstraZeneca are conducting additional trials investigating their drugs in earlier stages of triple-negative breast cancer. These studies explore the potential to shrink tumors before surgery and to eliminate residual cancer cells post-surgery, with the aim of improving long-term outcomes.

“This very impressive benefit in the metastatic setting makes us want to move these drugs into earlier-stage disease and try to cure more patients,” said Dr. Sara Tolaney of Dana-Farber Cancer Institute, who has been involved in trials for both therapies. The recent approvals signal a significant advance after decades of limited progress against this challenging cancer type.