As of Wednesday, there's an FDA-approved treatment option besides chemotherapy for people with triple-negative breast cancer that has spread to other parts of the body.
New Jersey company Immunomedics got accelerated approval for Trodelvy, as a drug that fills a serious need and is adjudged "reasonably likely" to be beneficial. Though it passed a clinical trial with 108 patients with metastatic breast cancer, Trodelvy still needs to undergo more clinical trials to fully verify that it works.
"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," FDA Oncology Center of Excellence Director Dr. Richard Pazdur said in a statement.
Before taking Trodelvy, patients must have gone through two other treatments, the FDA said. That's likely by the very nature of triple-negative breast cancer, which the agency says accounts for 20% of the worldwide breast cancer diagnoses.
"Triple-negative" breast cancer tests negative for three types of receptors, including human epidermal growth factor receptor 2 (HER2) protein, the approval announcement explains. That makes it invulnerable to hormonal therapy medicines or medicines that go after HER2.
Trodelvy goes after Trop-2, a receptor whose "expression in cancer cells has been correlated with drug resistance," according to a 2015 paper re-posted by the National Center for Biotechnology Information. Trop-2 also often drives the metastasizing of breast cancer and prostate cancer.
Trodelvy does come with the FDA's most serious alert, a Boxed Warning or "black box warning." The warning is for abnormally low levels of white blood cells, which fight infection, and severe diarrhea.
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