FDA Approves Sacituzumab Govitecan for Adults with Triple-Negative Breast Cancer
Findings from the phase 3 ASCENT trial demonstrate a clinically meaningful 57% reduction in the risk of disease worsening or death for patients receiving sacituzumab govitecan.
Officials with the FDA have granted approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received 2 more prior systemic therapies, including at least 1 for metastatic disease.1
“Women with triple-negative breast cancer have historically had very few effective treatment options and faced a poor prognosis,” said Aditya Bardia, MD, MPH, director of the breast cancer research program at Mass General Cancer Center, in a press release. “Today’s FDA approval reflects the statistically significant survival benefit seen in the landmark ASCENT study and positions sacituzumab govitecan-hziy as a potential standard of care for pre-treated TNBC.”2
The drug was granted accelerated approval in April 2020 for patients with mTNBC who have received at least 2 prior therapies for metastatic disease.1 The approval is based on the phase 3 ASCENT trial, a multicenter, open-label, randomized trial conducted in 529 patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior chemotherapies if progression occurred within 12 months.1
Participants were randomized 1:1 to receive sacituzumab govitecan, 10 mg/kg as an intravenous infusion, on days 1 and 8 of a 21-day cycle or physician’s choice of a single agent chemotherapy. The trial had a primary efficacy endpoint of progression-free survival (PFS) in patients without brain metastases at baseline. Additional efficacy endpoints included PFS for the full population both with and without brain metastases and overall survival (OS).1
According to a press release, the median PFS for patients receiving sacituzumab govitecan was 4.8 months compared with 1.7 months for patients receiving chemotherapy. The median OS was 11.8 months and 6.9 months, respectively. The recommended dose is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles, until disease progression or unacceptable toxicity.1
These findings represent a clinically meaningful 57% reduction in the risk of disease worsening or death, according to a press release.2 The investigators noted that the most common adverse reactions were nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain.1
Sacituzumab govitecan is directed to the Trop-2 receptor, a protein commonly expressed in multiple types of epithelial tumors, including TNBC, in which high expression is associated with poor survival and relapse. Prior to this FDA approval, patients with previously treated metastatic TNBC had few treatment options, according to the press release.2
“A metastatic TNBC diagnosis is frightening,” said Ricki Fairley, MBA, founder and CEO of Touch, the Black Breast Cancer Alliance, in the press release. “As an aggressive and difficult-to-treat disease, it’s a significant advance to have an FDA-approved treatment option with a proven survival benefit for patients with metastatic disease that continues to progress. For far too long, people with metastatic TNBC had very few treatment options. Today’s news continues the progress of bringing more options to treat this devastating disease.”2
1. FDA grants regular approval to Sacituzumab govitecan for triple-negative breast cancer [news release]. FDA; April 7, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-sacituzumab-govitecan-triple-negative-breast-cancer. Accessed April 8, 2021.
2. FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival [news release]. Gilead; April 7, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/4/fda-approves-trodelvy-the-first-treatment-for-metastatic-triplenegative-breast-cancer-shown-to-improve-progressionfree-survival-and-overall-surviv. Accessed April 8, 2021.