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The FDA announced accelerated approval of the drug called Trodelvy for patients with triple-negative breast cancer that has spread to other parts of the body and who have had at least two prior therapies.
"Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Dr. Richard Pazdur, FDA Oncology Center of Excellence director, said in a statement. "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,"
He added there is an "intense interest in finding new medications" to help treat this specific type of advanced breast cancer.
The drug targets the receptor that promotes the cancer's growth and spreads within the body. The FDA approved the drug following a Trodelvy trial of 108 metastatic triple-negative breast cancer patients, all of whom had at least two prior therapies.
More than half of patients who responded to the drug maintained their response to the drug, or tumor shrinkage, for six or more months, and 16.7 percent maintained their response for 12 or more months. Side effects include severe neutropenia and severe diarrhea, the FDA said.
"As part of FDA’s ongoing and aggressive commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease," Pazdur said.
The FDA approved the application for Trodelvy "more than a month ahead of the FDA goal date" despite the coronavirus pandemic, Pazdur added. "Our staff is continuing to meet with drug developers, academic investigators, and patient advocates to push forward the coordinated review of treatments for cancer."
More information about Trodelvy can be found on the FDA's website.