NCCN Guidelines: Updates from Recent FDA Approvals for Sacituzumab Govitecan-hziy

2021 Year in Review - Triple-Negative Breast Cancer

Sacituzumab govitecan-hziy (SG) is a first-in-class antibody and topoisomerase inhibitor conjugate that attaches to the Trop-2 receptor located on cancer tumor cells. Trop-2 is a protein that is overexpressed in multiple types of epithelial tumors, including metastatic triple-negative breast cancer (mTNBC), in which high expression is associated with decreased patient survival and higher rates of disease relapse.1 SG is indicated for adult patients with mTNBC who received ≥2 prior therapies, with ≥1 prior treatments for metastatic disease.1 The National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines now contain updates that include the recent FDA approvals of SG for this invasive breast cancer.2

SG was approved by the FDA for patients with previously treated mTNBC through a fast-track designation in April 2020. In April 2021, SG gained full FDA approval for mTNBC with an extended approved indication for second-line metastatic disease and became the first FDA-approved treatment for mTNBC shown to improve progression-free survival and overall survival.3

The NCCN guidelines recommend SG as a preferred regimen for treatment of adult patients with mTNBC, have received ≥2 prior therapies, ≥1 for metastatic disease. The NCCN also recommends SG as a second-line later therapy in patients with unresectable locally advanced or mTNBC.2 SG is the first monotherapy treatment to advance overall survival in mTNBC, a disease with limited treatment options.1

The results from the phase 3 ASCENT study, where SG showed a compelling 57% reduction in the risk of disease worsening or death, supported its inclusion in the NCCN guideline updates. In addition, SG extended median overall survival, showing an impressive 49% reduction in the risk of death.1

SG’s inclusion in the NCCN Breast Cancer Guidelines for mTNBC, supported by its full FDA approval in April 2021, will open the path for SG to be included in commercial and federal health insurance formularies. That will mean more patients will receive SG, a lifesaving treatment, improving on already robust patient support services. The NCCN guidelines are used by physicians across the country who now have a further tool against this difficult-to-treat form of breast cancer and give renewed hope to patients who suffer from this disease.1


  1. Gilead. Gilead statement on new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) recommendation for sacituzumab govitecan-hziy (Trodelvy) in second-line and later metastatic triple-negative breast cancer. Updated September 2021. Accessed December 1, 2021.
  2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancer. Version 8.2021. Updated September 13, 2021. Accessed December 1, 2021.
  3. US Food and Drug Administration. FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer. Accessed December 1, 2021.

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