FDA approves Trodelvy for first-line metastatic breast cancer

The FDA on Wednesday approved Trodelvy as a first-line treatment for metastatic triple-negative breast cancer, covering monotherapy and combination with Keytruda, according to Gilead Sciences .investors.gilead+1
The approval is backed by two Phase 3 trials showing Trodelvy reduced the risk of disease progression or death compared to standard chemotherapy by up to 38%.allsci+1
The decision follows the European Commission's marketing authorization for Trodelvy in the same setting granted one day earlier, establishing a new global standard of care.gilead

The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences' Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of metastatic triple-negative breast cancer, a decision that establishes the antibody-drug conjugate as a new standard of care for one of the most difficult-to-treat forms of the disease.lasvegassun+3

The approval covers two indications: Trodelvy as a monotherapy for patients who are not candidates for PD-1 or PD-L1 inhibitor therapy, and Trodelvy in combination with Merck's Keytruda (pembrolizumab) for patients whose tumors are PD-L1-positive.curetoday+1

A Shift Away From Chemotherapy

The monotherapy approval is supported by the Phase 3 ASCENT-03 trial, which demonstrated a 38% reduction in the risk of disease progression or death compared to physician's choice of chemotherapy. The combination indication draws on the ASCENT-04 trial, which showed a median progression-free survival of 11.2 months for Trodelvy plus Keytruda versus 7.8 months for chemotherapy plus Keytruda, representing a 35% reduction in the risk of progression or death.allsci+2

Triple-negative breast cancer accounts for roughly 10-15% of all breast cancers and lacks the three most common receptors targeted by existing therapies, leaving chemotherapy as the longstanding default. More than half of patients with metastatic TNBC never receive treatment beyond the first line, underscoring the urgency of effective initial therapy for a disease with a five-year survival rate of approximately 12%.curetoday

Global Momentum

The FDA decision comes just two days after the European Commission granted marketing authorization for Trodelvy as a first-line monotherapy for the same patient population across EU member states. The National Comprehensive Cancer Network had already updated its guidelines in January to list Trodelvy as a category 1 preferred first-line option for PD-L1-negative metastatic TNBC, its highest recommendation level.thepharmaletter+4

Trodelvy, a Trop-2-directed antibody-drug conjugate, was first granted accelerated approval in the United States in April 2020 for previously treated metastatic TNBC. Wednesday's approval marks its expansion into the front-line setting, where it now displaces chemotherapy as the preferred backbone treatment for a broader population of newly diagnosed metastatic patients.drugs+1

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