Update: FDA approves new treatment for metastatic triple-negative breast cancer

Update: FDA approves new treatment for metastatic triple-negative breast cancer

The FDA approved the use of sacituzumab govitecan-hizy (Trodelvy), a treatment drug for people with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. (4/27/20)

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This article is most relevant for:

People with metastatic triple-negative breast cancer who have received at least two prior lines of treatment

This article is also relevant for:

  • Breast cancer survivors
  • Men with breast cancer
  • Metastatic cancer
  • People with a genetic mutation linked to cancer risk
  • Triple negative breast cancer
  • Women under 45
  • Women over 45


At a glance
Clinical trials
Questions for your doctor
Resources and references
Rating Details


This report is about:

Approval of the drug Trodelvy (sacituzumab govitecan-hizy) for treating metastatic triple-negative breast cancer (TNBC).

Why is this approval important?

Metastatic triple-negative breast cancer is an aggressive type of cancer with few options for treatment beyond chemotherapy. On April 22, 2020 the U.S. Food and Drug Administration (FDA) granted accelerated approval of the drug Trodelvy for the treatment of advanced, triple-negative breast cancer. Trodelvy approval provides a new treatment option for TNBC metastatic breast cancer patients whose cancer has not responded or progressed after two previous lines of treatment.

Research findings:

FDA approval of Trodelvy was based on previous research, which we reported in this XRAY review. In this clinical trial of 108 patients with metastatic triple-negative breast cancer:

  • 1/3 of patients who took Trodelvy (33 percent) had their cancer shrink. Of these patients:
    • More than half (55 percent) had no cancer growth for six months.
    • 17 percent had no cancer growth for a year or longer.

As with most cancer medicines, Trodelvy may cause side effects. The most common side effects include:

  • Nausea
  • Neutropenia (abnormally low levels of white blood cells)
  • Diarrhea
  • Fatigue
  • Anemia
  • Vomiting
  • Hair loss
  • Constipation
  • Decreased appetite
  • Rash
  • Abdominal pain

The FDA label warns about the possibility of severe neutropenia or diarrhea.

What does this mean for me?

If you have been diagnosed with locally advanced or metastatic triple-negative breast cancer, you may want to talk to your doctor about Trodelvy.

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Expert Guidelines

The FDA approved Troveldy to treat metastatic TNBC in people who have had at least two prior lines of treatment.

The National Comprehensive Cancer Network (NCCN) is a national panel of experts that creates guidelines for cancer treatment. NCCN recommends the following testing for targeted therapy in people with metastatic TNBC:

  • for people with triple-negative metastatic breast cancer, PD-L1 biomarker testing can tell if they might benefit from the drug atezolizumab (Tecentriq).
  • for people with Her2-neu negative metastatic breast cancer, BRCA testing can tell if they might benefit from the PARP inhibitors Lynparza (olaparib) or Talzenna (talazoparib).

Questions To Ask Your Health Care Provider

  • Is Trodelvy a treatment option for my type of breast cancer?
  • If Trodelvy is not an option for me right now, might it be an option in the future?
  • What side effects might I experience with this treatment?
  • If I have serious side effects, will I need to stop treatment?
  • Are any other agents available to treat my cancer?

Open Clinical Trials

Rating Details:

Relevance: High

  • This approval could directly affect treatment recommendations for people with metastatic TNBC whose cancer has persisted or progressed after 2 prior lines of treatment.
  • This approval is less relevant for people with metastatic breast cancer, which is not TNBC.
  • The approval is likely to change practices for treatment of advanced, recurrent TNBC.

Research Timeline: Post Approval