FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer

The FDA has granted accelerated approval to Immunomedics’ Trodelvy (sacituzumab govitecan-hziy), the first antibody-drug conjugate that targets the Trop-2 antigen. Trodelvy is indicated for treatment of relapsed or refractory metastatic triple-negative breast cancer (TNBC).

Chemotherapy has been the standard treatment for TNBC, and patients who take Trodelvy must have received at least 2 previous therapies for the cancer. Further clinical trials are required to verify and describe the treatment’s clinical benefit.

“The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy,” stated Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence.

Worldwide, roughly 2 in 10 breast cancer diagnoses is for TNBC, meaning the cancer tests negative for estrogen receptors, progesterone receptors, and the human epidermal growth factor receptor 2 protein. Because of this, TNBC does not respond to hormonal therapy medicines.

“Trodelvy is a Trop-2—directed antibody and topoisomerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that helps the cancer grow, divide, and spread and is linked to topoisomerase inhibitor, which is a chemical compound that is toxic to cancer cells,” according to the FDA.

The agency based its approval on a single-arm, multicenter phase 2 study that included 108 patients with metastatic TNBC. Researchers found “the overall response rate was 33.3%, with a median duration of response of 7.7 months. Of the patients with a response to Trodelvy, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.”

The medication includes a black box warning that patients who receive the treatment may experience severe neutropenia (abnormally low white blood cells) or severe diarrhea. Additional therapy that stimulates patients’ bone marrow to produce white blood cells may be warranted should neutropenia occur.

According to researchers, the most common adverse effects reported by patients were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.

“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 in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer,” said Loretta Itri, MD, chief medical officer of Immunomedics. “We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need.”