As of Wednesday, alongside chemotherapy, there has been an FDA-approved treatment option for people with triple-negative breast cancer that has spread to other parts of the body, and the New Jersey company Immunomedics has received accelerated approval for Trodelvy as a drug that meets a serious need and is judged to be “with sufficient probability” advantageous.
Although there has been a clinical trial in 108 patients with metastatic breast cancer, Trodelvy needs to undergo further clinical trials to fully test its functionality. ”Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options.
Chemotherapy is the mainstay of treatment for triple-negative breast cancer, ”said the director of the FDA Oncology Center of Excellence, Dr.
Richard Pazdur, in a statement, said that before taking Trodelvy, patients must have had two other treatments, the FDA said.
This is likely due to the nature of triple-negative breast cancer, which, according to the agency, accounts for 20% of breast cancer diagnoses worldwide. “Triple-negative” breast cancer tests are negative for three types of receptors, including human epidermal growth factor receptor 2 (HER2) – Proteins, explains the approval notice.
This makes them invulnerable to hormone therapy drugs or drugs that go after HER2. Trodelvy is after Trop-2, a receptor whose “expression in cancer cells has been correlated with drug resistance”, as new in a 2015 by the National Center for Biotechnology Information published paper is called.
Trop-2 also often drives breast cancer and prostate cancer metastasis.
Trodelvy comes with the FDA’s most serious warning, a boxed warning or black box warning.
The warning relates to abnormally low levels of white blood cells that fight infection, and …
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