WASHINGTON — Sacituzumab govitecan-hziy (Trodelvy) is now FDA-approved to treat adults with metastatic triple-negative breast cancer.
The drug — which the FDA granted accelerated approval, as well as Priority Review, Fast Track, Breakthrough Therapy designations — is a Trop-2-directed antibody and topoisomerase inhibitor conjugate that works by targeting the Trop-2 receptor, preventing the cancer from growing and spreading. In order to take this drug, patients with metastatic triple-negative breast cancer must have tried at least two prior therapies.
“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. The approval of [sacituzumab govitecan-hziy] today represents a new targeted therapy for patients living with this aggressive malignancy,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. “There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. Today’s approval provides patients who’ve already tried two prior therapies with a new option.”
This approval was based on results from a clinical trial involving 108 patients with metastatic triple-negative breast cancer who received a minimum of two prior treatments. According to the FDA, the overall response rate was 33.3%, with a median duration of response of 7.7 months. And, of the patients who responded to sacituzumab govitecan-hziy, “55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months,” the agency added.
Common side effects reported in patients taking sacituzumab govitecan-hziy included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.
Sacituzumab govitecan-hziy carries a Boxed Warning to inform patients and health care providers of a severe risk of neutropenia and severe diarrhea among patients taking the drug.
Health care professionals should monitor patient’s blood cell counts periodically during treatment with [sacituzumab govitecan-hziy] and consider treatment with a type of therapy called granulocyte-colony stimulating factor (G-CSF), which stimulates the bone marrow to produce white blood cells called granulocytes and stem cells and releases them into the bloodstream, to help prevent infection, and should initiate anti-infective treatment in patients with febrile neutropenia.
“Additionally, health care professionals should monitor patients with diarrhea and give fluid, electrolytes, and supportive care medications, as needed,” the agency continued. “[Sacituzumab govitecan-hziy] may need to be withheld, dose reduced or permanently discontinued for neutropenia or diarrhea. [Sacituzumab govitecan-hziy] can cause hypersensitivity reactions including severe anaphylactic reactions. Patients should be monitored for infusion-related reactions and health care professionals should discontinue [sacituzumab govitecan-hziy] if severe or life-threatening reactions occur. If patients experience nausea or vomiting while taking [sacituzumab govitecan-hziy], health care professionals should use antiemetic preventive treatment, to prevent nausea and vomiting. Patients with reduced uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) activity are at increased risk for neutropenia following initiation of [sacituzumab govitecan-hziy] treatment.”
In addition, the FDA warned that women who are pregnant should not take the drug, as it may harm a developing fetus or newborn baby, and that women of reproductive age should use contraception during treatment and for 6 months after the last dose; men with female partners of reproductive age should also use contraception over the course of treatment and for three months after the last dose.
Sacituzumab govitecan-hziy is manufactured by Immunomedics, Inc.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 22
Topic ID: 78,22,730,22,691,192