Gilead receives CHMP positive opinion for Trodelvy in 1L metastatic TNBC patients ineligible for PD-(L)1 inhibitors

CAR-T Digest - August 2020

Weekly Digest - May 2026

22 May 2026: Gilead receives CHMP positive opinion for Trodelvy in 1L metastatic TNBC patients ineligible for PD-(L)1 inhibitors

Gilead has received a positive CHMP opinion for Trodelvy in the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients who are not eligible for PD-1/PD-L1 inhibitor therapy, potentially expanding the use of its flagship ADC into an earlier treatment setting with significant unmet need
The recommendation was supported by results from the Phase 3 ASCENT-03 trial, where Trodelvy demonstrated a highly statistically significant and clinically meaningful progression-free survival benefit versus standard chemotherapy, including a 38% reduction in the risk of disease progression or death in PD-(L)1 inhibitor-ineligible patients
The positive opinion further strengthens the clinical validation of Trop-2 as a key therapeutic target in breast cancer and reinforces the growing importance of ADCs in reshaping treatment algorithms across earlier lines of therapy
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate that utilizes a hydrolyzable linker to deliver the topoisomerase I inhibitor payload SN-38, enabling potent antitumor activity along with a bystander effect within the tumor microenvironment
Strategically, the potential approval would enhance Trodelvy’s competitive position in metastatic TNBC as the TROP2 landscape becomes increasingly crowded, while supporting Gilead’s broader objective of expanding the product beyond later-line use and establishing it as a foundational therapy across multiple breast cancer settings