Gilead Sciences gains EU approval for Trodelvy in first-line metastatic TNBC
- Gilead Sciences (NASDAQ:GILD) received European Commission approval for Trodelvy as first-line monotherapy for unresectable or metastatic triple-negative breast cancer in patients ineligible for PD-1/PD-L1 inhibitors.
- Trodelvy becomes the first antibody-drug conjugate approved in this first-line setting in the European Union.
- The approval was based on the Phase 3 ASCENT-03 study showing improved progression-free survival versus chemotherapy.
Gilead Sciences (NASDAQ:GILD) announced that the European Commission has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) as monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who have not received prior systemic therapy and are not candidates for PD-1 or PD-L1 inhibitor treatment.
This marks the first approval of an antibody-drug conjugate for first-line metastatic TNBC in the European Union’s 27 member states plus Norway, Iceland and Liechtenstein.
“This approval brings a profound sense of hope to a community that has long been waiting for progress,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain.
The decision is based on the Phase 3 ASCENT-03 study, in which Trodelvy demonstrated a 38% reduction in the risk of disease progression or death compared with standard chemotherapy.
Gilead Sciences noted the study used a crossover design, allowing chemotherapy patients to switch to Trodelvy upon progression.
Gilead Sciences has also submitted filings for Trodelvy in combination with Keytruda for PD-L1 positive patients in Europe and multiple filings in the United States for first-line use.
Trodelvy is an antibody-drug conjugate designed to target Trop-2 expressing cancer cells and deliver a chemotherapy payload.
The company continues to advance Trodelvy across multiple indications as it seeks to expand its role as a treatment option for metastatic triple-negative breast cancer patients in different lines of therapy and biomarker subgroups.
