With expanded indication, Trodelvy set to become Gilead's blockbuster

With its recently granted expanded approval by the US Food and Drug Administration (FDA) for Gilead Sciences’ (Nasdaq: GILD) Trodelvy (sacituzumab govitecan-hziy) - for patients with HR-positive/HER2-negative metastatic breast cancer who have received hormonal therapy and at least two additional therapies – the drug is expected to become a standard of care for these breast cancer patients, who have had limited treatment options.

This is Trodelvy’s second approval for breast cancer patients after it started being marketed for triple-negative breast cancer in 2021. Sales of the drug rose 79% from $380 million in 2021 to $680 million in 2022. GlobalData's analyst consensus forecasts project Trodelvy sales to reach 2.8 billion by 2028.

“Patients with HR+/HER2- metastatic breast cancer who are treated with hormone therapy and chemotherapy often develop resistance to these treatments. Trodelvy, an antibody-drug conjugate (ADC) that targets the Trop-2 protein found on the surface of most breast cancer cells, presents a statistically significant improvement in overall survival compared to retreating with chemotherapy,” commented GlobalData’ oncology and hematology analyst Israel Stern.