FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

Regulatory approval: On June 24, 2026, the FDA approved sacituzumab govitecan-hziy (Trodelvy) for two first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC): (1) monotherapy for patients not candidates for PD-1/PD-L1 inhibitor–based therapy (ASCENT-03) and (2) in combination with pembrolizumab (or pembrolizumab and berahyaluronidase alfa-pmph) for PD-L1–positive disease (CPS ≥10) by an FDA-authorized test (ASCENT-04/KEYNOTE D-19).

FDA approval (June 24, 2026): sacituzumab govitecan-hziy in first-line TNBC

The FDA approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences) for two first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC):

  1. Monotherapy for patients not candidates for PD-1/PD-L1 inhibitor–based therapy, supported by ASCENT-03 (NCT05382299).

  2. Combination therapy with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for tumors expressing PD-L1 (CPS ≥10) by an FDA-authorized test, supported by ASCENT-04/KEYNOTE-D19 (NCT05382286).

Key efficacy results

ASCENT-03 (n=558; open-label, randomized): sacituzumab govitecan-hziy vs treatment of physician’s choice (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin). Primary endpoint PFS by BICR (RECIST v1.1).

  • Median PFS: 9.7 vs 6.9 months (HR 0.62, p<0.0001)
  • Confirmed ORR: 50% vs 47%
  • OS data were immature

ASCENT-04/KEYNOTE-D19 (n=443; PD-L1 CPS ≥10): sacituzumab govitecan-hziy + pembrolizumab vs TPC + pembrolizumab. Primary endpoint PFS by BICR.

  • Median PFS: 11.2 vs 7.8 months (HR 0.65, p=0.0009)
  • Confirmed ORR: 61% vs 55%
  • OS data were immature

Safety and dosing (label highlights)

Trodelvy includes a boxed warning for diarrhea and neutropenia. Recommended dose: 10 mg/kg IV on Days 1 and 8 of each 21-day cycle, continued until progression or unacceptable toxicity.

The FDA review was conducted under Project Orbis; reviews at partner agencies are ongoing.

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