The FDA has expanded approval of a targeted therapy from Gilead Sciences as a new first-line treatment for triple-negative breast cancer, increasing competition with a rival drug in the same class that also recently received approval as an earlier treatment for that cancer.
Gilead’s Trodelvy was first launched on the market in 2020 as a third-line treatment for triple-negative breast cancer. Wednesday’s regulatory decision moving it to the first line of treatment is important because the aggressive nature of this type of cancer means many patients do not live long enough to receive treatment that is only available in later settings.
Triple negative breast cancer gets its name from the absence of three receptors found in other breast cancers. Therapies targeted at these receptors will not work. Until last month, the first line of treatment for triple-negative breast cancer was 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. This is what made the month of May accelerated approval of AstraZeneca and Daiichi Sankyo drug Datroway notable. This regulatory decision authorizes the use of this drug as first-line treatment to treat people not eligible for Keytruda, thus offering these patients an alternative to immunotherapy.
Like the approval of Datroway, the expanded label for Gilead’s Trodelvy also covers 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 the use of Trodelvy with intravenously infused Keytruda and Keytruda. Keytruda Qlex, which is the version injected subcutaneously of Merck medicine.
“This approval is encouraging news for patients and the clinical community, and I believe it provides a practice-changing first-line treatment option for all patients regardless of PD-L1 status,” said Dr. Sara Tolaney, chief of the division of breast oncology at Dana-Farber Cancer Institute and principal investigator of the Trodelvy studies, in a prepared statement.
Trodelvy is an antibody-drug conjugate (ADC) designed to target TROP2, a protein abundant on the surface of many types of cancer cells, including those in triple negative breast cancer. FDA approval in 2020 made this drug the first TROP2-targeting ADC approved. It has since added metastatic urothelial cancer and HR-positive, HER2-negative metastatic breast cancer to its label. This drug from Gilead is a blockbuster product, accounting for nearly $1.4 billion in global revenue in 2025, an increase of 6% from the previous year.
Datroway, an ADC targeting TROP2 from Daiichi Sankyo Laboratories, was developed in a partnership with AstraZeneca. Thanks to Trodelvy’s lead in the market, Datroway is gaining ground, gaining three FDA approvals in the past 18 months. 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 could still reach the market in combination with Keytruda as a treatment for triple negative breast cancer. A phase 3 study evaluating the drug combination is underway.
Photo by Gilead Sciences