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Trodelvy

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Trodelvy (chemical name: sacituzumab govitecan-hziy) is approved to treat adults diagnosed with metastatic triple-negative breast cancer who have received at least two previous treatments for metastatic disease.

Metastatic breast cancer is breast cancer that has spread to parts of the body away from the breast, such as the bones or liver.

Triple-negative breast cancer is cancer that has no receptors for the hormones estrogen and progesterone, as well as no receptors for the HER2 protein. This limits the medicines that can be used to treat the cancer.

Trodelvy is an immune targeted therapy medicine. It is made up of:

  • sacituzumab, a type of molecule called a monoclonal antibody, that targets the Trop-2 protein; the Trop-2 protein is found in more than 90% of triple-negative breast cancers
  • SN-38, a topoisomerase I inhibitor chemotherapy; topoisomerase I inhibitors work by interfering with the cancer cells’ ability to replicate
  • a compound that links the sacituzumab to the SN-38

Doctors call Trodelvy an antibody-drug conjugate. The linking compound attaches (conjugates) the monoclonal antibody sacituzumab to the SN-38 chemotherapy.

Trodelvy is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or port. Trodelvy is given once weekly on day one and day eight of a continuous 21-day treatment cycle, unless the cancer grows or unacceptable side effects develop.

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How Trodelvy works

Research has shown that the Trop-2 protein is found on the surface of more than 90% of triple-negative breast cancers. Sacituzumab, one of the compounds that makes up Trodelvy, targets the Trop-2 protein and attaches to it. SN-38, the topoisomerase I inhibitor chemotherapy part of Trodelvy, like other chemotherapy medicines, interferes with a cell’s ability to replicate. SN-38 isn’t a targeted medicine, which means it can affect healthy cells as well as cancer cells.

Trodelvy was designed to deliver the SN-38 chemotherapy to cancer cells in a targeted way by attaching the SN-38 to the sacituzumab. The sacituzumab then carries the SN-38 to the triple-negative cancer cells. This way, the SN-38 is less toxic to healthy cells and more effective in treating cancer cells.

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Is Trodelvy right for you?

Trodelvy is used to treat people diagnosed with metastatic triple-negative breast cancer that has previously been treated with at least two therapies. This means that the metastatic cancer has stopped responding to at least two other treatments.

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What to expect during treatment with Trodelvy

Trodelvy is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or port. Trodelvy is given once weekly on day one and day eight of a continuous 21-day treatment cycle, unless the cancer grows or unacceptable side effects develop.

One of the serious side effects of Trodelvy is neutropenia, abnormally low levels of neutrophils, a type of white blood cell. People with neutropenia have a much higher risk of getting serious infections. People who are homozygous for the UGT1A1 alleles — meaning both of the alleles that make up the pair of UGT1A1 genes are the same — have a higher risk of developing neutropenia. People who are homozygous for the UGT1A1 alleles should be closely monitored for severe neutropenia.

It's important to know that women who are pregnant or planning to get pregnant should not take Trodelvy. Trodelvy can harm the developing fetus. If there is any chance you can become pregnant, you must use effective birth control while you're taking Trodelvy and for at least 6 months after your last dose. Men who are taking Trodelvy should use effective birth control while taking Trodelvy and for at least 3 months after their last dose. Visit Treatment for Breast Cancer During Pregnancy for more information.

Also, women who are breastfeeding or plan to breastfeed shouldn't take Trodelvy. Together, you and your doctor will decide if you should take Trodelvy or breastfeed.

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Trodelvy side effects

The most common side effects caused by Trodelvy are:

Trodelvy also may cause serious side effects, including:

  • Severe neutropenia: Neutropenia means you have abnormally low levels of neutrophils, a type of white blood cell. People with neutropenia have a much higher risk of getting serious infections. Your doctor will monitor your neutrophil counts while you are being treated with Trodelvy. If you develop neutropenia, you may be treated with a granulocyte-colony stimulating factor medicine such as Neupogen (chemical name: filgrastim), Neulasta (chemical name: pegfilgrastim), or Zarxio (chemical name: filgrastim-sndz).
  • Severe diarrhea: Severe diarrhea can cause dehydration, low blood pressure, and severe kidney problems. Tell your doctor about any diarrhea you have so it can be treated right away.

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References

  1. Trodelvy (sacituzumab govitecan-hziy) prescribing information. Immunomedics, Morris Plains, NJ. 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf. (PDF)

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