FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On February 3, 2023, the FDA approved sacituzumab govitecan-hziy (brand name Trodelvy) for patients with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Efficacy was evaluated in TROPiCS-02, a multicenter, open label, randomized study in 543 patients with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer whose disease progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane. Patients received at least two prior chemotherapies in the metastatic setting.
Patients were randomized 1:1 to sacituzumab govitecan-hziy. Randomization was stratified by the following factors: prior chemotherapy regimens for metastatic disease, visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months. Patients were treated until disease progression or unacceptable toxicity.
The primary efficacy outcome measure was progression-free survival determined by blinded independent central review per RECIST v1.1. A key secondary efficacy outcome measure was overall survival. Median progression-free survival was 5.5 months in the sacituzumab govitecan-hziy arm and 4 months in the single agent chemotherapy arm. Median overall survival was 14.4 months for those receiving sacituzumab govitecan-hziy and 11.2 months for those receiving single agent chemotherapy.
The most common adverse events occurring in more than 25% of patients treated with sacituzumab govitecan-hziy in TROPiCS-02 including laboratory abnormalities, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, increased glucose, constipation, and decreased albumin.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found at www.fda.gov/drugsatFDA.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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