FDA Approval Insights: Sacituzumab Govitecan in HR-positive, HER2-negative Breast Cancer

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Dr Tolaney discusses the FDA approval of sacituzumab govitecan in patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer; key data from the TROPiCS-02 trial; and how this agent can fulfill unmet needs for this patient population.

Welcome to OncLive On Air®! I’m your host today, Chris Ryan.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Gilead Sciences, we had the pleasure of speaking with Sara M. Tolaney, MD, MPH, about the FDA approval of sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer. Dr Tolaney is chief of the Division of Breast Oncology and associate director of the Susan F. Smith Center for Women’s Cancers, a senior physician at Dana-Farber Cancer Institute, and an associate professor of medicine at Harvard Medical School in Boston, Massachusetts.

On February 3, 2023, the FDA approved sacituzumab govitecan for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. The decision was supported by data from the phase 3 TROPiCS-02 trial (NCT03901339), which showed that sacituzumab govitecan demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) over physician’s choice of single-agent chemotherapy. Sacituzumab govitecan elicited a median OS of 14.4 months compared with 11.2 months for chemotherapy.

In our exclusive interview, Dr Tolaney discussed the implications of the approval of sacituzumab govitecan in this setting, key efficacy and safety data from TROPiCS-02, and how this agent can fulfill unmet needs for this patient population.

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