The U.S. Food and Drug Administration (FDA) has announced an accelerated approval of a drug called Trodelvy (sacituzumab govitecan-hziy) for the treatment of metastatic triple-negative breast cancer (TNBC) in adult patients.
The FDA approval was based on the results of a study of Trodelvy in TNBC.
Lead study investigator Dr. Aditya Bardia said, “The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease.”
Dr. Bardia is the director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center.
“In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer,” added Dr. Bardia, which is also an assistant professor of medicine at Harvard Medical School.
Common side effects were experienced by 85 percent of the patients who received treatment with Trodelvy, while serious side effects were reported in 35 percent of the patients.
The most common side effects were neutropenia, anemia, leucopenia (decreased white-cell count), hypophosphatemia, diarrhea, fatigue, and asthenia.
The FDA’s accelerated approval of Trodelvy in this setting is contingent on the findings of a confirmatory trial.
Immunomedics, a New Jersey-based pharmaceutical company, develops Trodelvy.
CEO of Immunomedics. Dr. Loretta Itri said, “We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer.”
“This approval highlights the potential of our unique ADC platform and strengthens the premise that the Trop-2 antigen found in many solid cancers is an important target for drug delivery,” Dr. Itri added. “We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need.”
