The FDA has expanded the approval of a targeted Gilead Sciences therapy as a new first-line treatment for triple-negative breast cancer, tightening competition with a rival drug from the same class that also recently received approval as an earlier treatment for this cancer.
Gilead’s Trodelvy first reached the market in 2020 as a third-line treatment for triple-negative breast cancer. The Wednesday regulatory decision moving it up to the first line of therapies is important because the aggressive nature of this type of cancer means that many patients do not live long enough to receive a treatment that’s only available in later settings.
Triple-negative breast cancer is named for its lack of three receptors found in other breast cancers. Targeted therapies for those receptors won’t work. Until last month, the first line of treatments for triple-negative breast cancer were chemotherapy and Merck’s Keytruda, an immunotherapy that works by blocking PD-1, a so-called checkpoint protein found on T cells.
Not all patients are eligible for treatment with immunotherapy. That’s what made the May accelerated approval of AstraZeneca and Daiichi Sankyo drug Datroway notable. That regulatory decision permits first-line use of this drug to treat those ineligible for Keytruda, giving these patients an alternative to immunotherapy.
Like the Datroway approval, the expanded label for Gilead’s Trodelvy also covers the treatment of patients ineligible for immunotherapy. But the FDA also approved Trodelvy in combination with Keytruda based on Gilead’s additional clinical testing of Trodelvy with the immunotherapy. The latest regulatory decision covers use of Trodelvy alongside both intravenously infused Keytruda and Keytruda Qlex, which is the subcutaneously injected version of the Merck drug.
“This approval is heartening news for patients and the clinical community, and I believe offers a practice-changing first-line treatment option for all patients across PD-L1 status,” Dr. Sara Tolaney, chief of the division of breast oncology at Dana-Farber Cancer Institute and a principal investigator of the Trodelvy studies, said in a prepared statement.
Trodelvy is an antibody drug conjugate (ADC) designed to target TROP2, a protein that’s abundant on the surface of many types of cancer cells, including those of triple negative breast cancer. The 2020 FDA nod made this drug the first approved TROP2-targeting ADC. It has since added metastatic urothelial cancer and metastatic HR-positive, HER2-negative breast cancer to its label. This Gilead drug is a blockbuster seller, accounting for nearly $1.4 billion in global revenue in 2025, a 6% increase compared to the prior year.
Datroway, a TROP2-targeting ADC from the labs of Daiichi Sankyo, was developed under a partnership with AstraZeneca. Through Trodelvy had a head start in the market, Datroway is gaining ground, racking up three FDA approvals in the past 18 months spanning HR-positive, HER2-negative breast cancer; EGFR-mutated lung cancer; and last month’s approval for first-line treatment of triple-negative breast cancer. Datroway may yet reach the market paired with Keytruda as a treatment for triple-negative breast cancer. A Phase 3 study evaluating the drug combination is ongoing.
Photo by Gilead Sciences
