Breast CancerFDA Approvals, News & UpdatesMetastatic Breast Cancer

New Targeted Therapy for Patients with Metastatic Triple-Negative Breast Cancer

People with triple-negative breast cancer (TNBC) that has spread to other parts of the body (metastatic) now have a new treatment option called Trodelvy (sacituzumab govitecan-hziy). This drug was recently approved by the Food and Drug Administration (FDA) for use specifically in adult patients with metastatic TNBC who have already received at least 2 previous treatments for their cancer.
January 2021 – A Patient Guide to Recent FDA-Approved Oncology Drugs

People with triple-negative breast cancer (TNBC) that has spread to other parts of the body (metastatic) now have a new treatment option called Trodelvy (sacituzumab govitecan-hziy). This drug was recently approved by the Food and Drug Administration (FDA) for use specifically in adult patients with metastatic TNBC who have already received at least 2 previous treatments for their cancer.

In response to the drug’s approval, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said: “Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy….Today’s approval provides patients who’ve already tried 2 prior therapies with a new option.”

TNBC is breast cancer that is negative for the estrogen hormone receptor, the progesterone hormone receptor, and the human epidermal growth factor receptor 2 (HER2). It accounts for 10% to 15% of all breast cancers and is harder to treat than other types of invasive breast cancer because it is more aggressive, and it typically leads to worse outcomes. In fact, only about 11% of women who are diagnosed with metastatic TNBC will be alive 5 years after their diagnosis.

This disease also tends to affect more younger patients than other types of breast cancer, with a substantial number of diagnoses occurring in people younger than 60 and even 50 years. Although advancements in breast cancer treatment have led to a number of effective therapies, including hormone therapy or HER2-targeted therapies (like trastuzumab), and endocrine therapies (like tamoxifen or aromatase inhibitors), unfortunately, TNBC does not respond to these treatments.

So, the gold standard of treatment for patients with metastatic TNBC is chemotherapy, while other treatment options include PARP inhibitors and immunotherapies (a type of treatment that harnesses a patient’s own immune system to fight the cancer).

People with metastatic TNBC that has not responded to other therapies typically have limited treatment options, but with the approval of Trodelvy for this type of cancer, patients may now have hope for a better prognosis.

How to Take Trodelvy

Before taking Trodelvy, patients should tell their doctor about any medical conditions, including if they have been told that they carry a gene for uridine diphosphate-glucuronosyl transferase A1 (UGT1A1)*28 because people who carry this gene have an increased risk of side effects (especially low white blood cell counts), or if they have liver problems.

Women who are pregnant or plan to become pregnant should not take this drug as it can cause harm to an unborn baby or result in a miscarriage. Females who can become pregnant should always use effective birth control when taking this drug, and for 6 months after their final dose, while males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the final dose. Trodelvy may also cause fertility problems in females, so if this is a concern, women considering this drug should talk with their doctor first about fertility preservation options.

Women should not breastfeed while taking this drug, or for 1 month after their last dose. Patients should also tell their healthcare provider about any prescription and over-the-counter medicines they take, including vitamins and herbal supplements, as certain medicines might affect the way it works.

Trodelvy is given by intravenous infusion at a recommended dose of 10 mg/kg once a week

on days 1 and 8 of continuous 21-day treatment cycles. The first dose will be given over the course of 3 hours, and if that dose is well tolerated, future doses may be given over 1 to 2 hours. This dosing schedule should continue until the cancer progresses or side effects become too severe.

Side Effects of Trodelvy

Before treatment, patients should receive medication to prevent infusion reactions and chemotherapy-induced nausea and vomiting, as these side effects can sometimes be severe. Patients should call their healthcare provider right away if they have nausea or vomiting that is not controlled with the medicines they have been prescribed.

Patients should always be monitored during the infusion and for at least 30 minutes after it ends, in case of any infusion-related side effects. If these side effects do occur, reducing the dose or stopping treatment altogether might be necessary.

Trodelvy can also cause other serious side effects, including low white blood cell count, or neutropenia. Neutropenia is common with this drug and can sometimes lead to life-threatening infections, so patients should always have their blood cell counts checked during treatment. If the white blood cell count is too low, an additional medication might be needed, or it may be necessary to lower the dose of Trodelvy or to stop treatment. If a fever develops due to neutropenia, antibiotic medication might be necessary. Patients should call their provider right away if they develop any of the following signs of infection during treatment: fever, chills, cough, shortness of breath, or burning or pain when urinating.

Diarrhea is also common with this drug, and it can be severe. Patients should be monitored for diarrhea and given medications as needed to keep it under control. If necessary, they should be given fluids and electrolytes to replace body salts in the case of dehydration. If diarrhea is severe enough and cannot be controlled with antidiarrheal medicines, decreasing the dose or stopping treatment with Trodelvy might be necessary. The first time diarrhea occurs on treatment, patients should let their doctor know right away. They should also inform their doctor if they have black or bloody stools; if they have symptoms of dehydration, such as lightheadedness, dizziness or faintness; if they are unable to take fluids by mouth due to nausea or vomiting; and/or if they are unable to get their diarrhea under control within 24 hours.

In addition to these, other common side effects of Trodelvy include feeling tired, decreased red blood cell count (anemia), hair loss, constipation, rash, decreased appetite, and stomach pain. However, these are not all of the possible side effects of Trodelvy, and patients using this drug should call their doctor with any concerns.

Sarlis Says

Trodelvy is an innovative drug designed to selectively target triple-negative breast cancer. It shows encouraging efficacy in the third-line setting, thereby adding to the disease-controlling options for women with this difficult-to-treat malignancy.

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Last modified: February 11, 2021

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