On Jun. 24, 2026, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy^® (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy is now approved in first-line mTNBC either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda^® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

The FDA approval is based on highly statistically significant and clinically meaningful progression-free survival (PFS) data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, where Trodelvy-based regimens significantly reduced the risk of disease progression or death in first-line mTNBC—by 38% as monotherapy versus chemotherapy in PD-L1 ineligible disease in ASCENT-03 and by 35% in combination with Keytruda versus Keytruda plus chemotherapy in PD-L1+ disease in ASCENT-04.

Across ASCENT-03 and ASCENT-04, Trodelvy-based regimens delivered markedly more durable responses, with median duration of response of 12.2 versus 7.2 months with chemotherapy in ASCENT-03 and 16.5 versus 9.2 months for Trodelvy plus Keytruda versus Keytruda plus chemotherapy in ASCENT-04 by blinded independent central review.

Based on the ASCENT-03 and ASCENT-04 positive study results, the National Comprehensive Cancer Network^® (NCCN^®) recommends Trodelvy with or without Keytruda as a category 1 preferred first-line treatment option for people with mTNBC across PD-L1 status in the NCCN Guidelines^®i. Trodelvy also has a category 1 recommendation in second-line mTNBC and in pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer (mBC).

Healthcare professionals have well-established experience with Trodelvy, with more than 75,000 breast cancer patients treated across more than 60 countries over the past six years. It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- mBC. It is also the only ADC with four positive Phase 3 trials in HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) mBC.