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FDA Grants Approval to Sacituzumab Govitecan-Hziy for TNBC

Triple-negative breast cancer.

Accelerated approval was granted to sacituzumab govitecan-hziy (Trodelvy, Immunomedics, Inc), a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, for patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies. Sacituzumab govitecan-hziy works by targeting the Trop-2 receptor, mitigating cancer growth and spread. In addition, this drug is linked to topoisomerase inhibitor, which is a chemical compound toxic to cancer cells.

"Metastatic [TNBC] is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for [TNBC]. The approval of [sacitizumab govitecan-hziy] today represents a new targeted therapy for patients living with this aggressive malignancy," commented 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. "There is intense interest in finding new medications to help treat metastatic [TNBC]. Today's approval provides patients who've already tried two prior therapies with a new option."

Approval was based on a clinical trial (NCT01631552) that enrolled 108 patients with metastatic TNBC that had received at least two prior therapies. Patients received sacituzumab govitecan-hziy intravenously on days 1 and 8 on a 21-day cycle until disease progression or unacceptable side effects.

After a median follow-up of 9.7 months, the response rate was 33.3%, with complete responses in 3 patients. Treatment-related adverse events included nausea (67%), neutropenia (64%), diarrhea (62%), fatigue (55%), and anemia (50%). Grade 3/4 side effects included neutropenia (32%), anemia (11%), and a decreased white-cell count (11%).

"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," concluded Dr. Pazdur. "At this critical time, we continue to expedite oncology product development. This application was approved more than a month ahead of the FDA goal date – an example of that commitment. Our staff is continuing to meet with drug developers, academic investigators, and patient advocates to push forward the coordinated review of treatments for cancer."

For More Information

Bardia A, Mayer IA, Vahdat LT, et al (2019). Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med, 380:741-751. DOI:10.1056/NEJMoa1814213

Clinicaltrials.gov (2020). Phase I/II study of IMMU-132 in patients with epithelial cancers. NLM Identifier: NCT01631552

Trodelvy (sacituzumab govitecan-hziy) prescribing information (2020). Immunomedics, Inc. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf

Image Courtesy of National Cancer Institute

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