Gilead Sciences’ Trodelvy won FDA approval for first-line triple-negative breast cancer (TNBC) regardless of PD-L1 status, strengthening its competitive position in the TROP2 antibody-drug conjugate race. The label supports Trodelvy as monotherapy for patients not eligible for PD-1/L1 inhibitors and as a combination with Merck’s Keytruda for PD-L1-positive tumors with a CPS of at least 10. The approval is backed by two phase 3 trials. In Ascent-03, Trodelvy reduced the risk of progression or death by 38% versus chemotherapy in PD-(L)1 treatment-ineligible patients. In Ascent-04 (Keynote-D19), Trodelvy plus Keytruda improved progression-free survival by 35% versus Keytruda and chemotherapy in PD-L1-positive disease. Analysts and clinicians will now compare how the PD-L1 requirements and cross-trial efficacy profiles stack up against AstraZeneca and Daiichi Sankyo’s Datroway program. The FDA’s decision broadens Trodelvy’s practical use while keeping the market dynamic for future head-to-head label expansions.