Gilead Sciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). The approval establishes Trodelvy as a new backbone therapy and the only approved antibody-drug conjugate (ADC) in first-line mTNBC across PD-L1 status. This regulatory milestone follows the recent European Commission marketing authorization for the therapy in first-line metastatic TNBC.

The FDA approval covers Trodelvy as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy, or in combination with Merck & Co Inc.'s Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10). The authorization is based on data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials. In the ASCENT-03 study, Trodelvy monotherapy reduced the risk of disease progression or death by 38% compared to chemotherapy in PD-L1 ineligible disease. In the ASCENT-04 study, Trodelvy plus Keytruda reduced the risk by 35% versus Keytruda plus chemotherapy in PD-L1+ disease.

"For people living with mTNBC, the first treatment choice can be pivotal, as many patients may not have the opportunity to receive subsequent therapies," said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. "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."

Trodelvy-based regimens demonstrated more durable responses compared to standard care. The median duration of response was 12.2 months versus 7.2 months with chemotherapy in ASCENT-03, and 16.5 months versus 9.2 months for Trodelvy plus Keytruda versus Keytruda plus chemotherapy in ASCENT-04. The National Comprehensive Cancer Network (NCCN) has updated its guidelines to recommend Trodelvy with or without Keytruda as a category 1 preferred first-line treatment option for people with mTNBC across PD-L1 status.

Key Details of the Authorization

"The FDA’s approval of Trodelvy provides a new standard of care for the most aggressive form of breast cancer," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "Building on its impact in second-line mTNBC, Trodelvy now offers patients a powerful new backbone therapy option in the first-line setting."

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Investment Growth Analysis

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Key Performance Metrics

The data illustrates how consistent returns can significantly multiply initial capital over a 20-year horizon. Gilead Sciences' ability to deliver market-beating returns has resulted in nearly a nine-fold increase on a hypothetical investment made two decades ago.