EU Approves Trodelvy + Keytruda Combo for First-Line Metastatic TNBC
GILD sits 35% above its 52-week low of $108.46.
Summary
The European Commission approved Trodelvy in combination with Merck's Keytruda for first-line metastatic triple-negative breast cancer in patients with PD-L1 CPS ≥10. This is the first ADC plus immunotherapy combination approved in this setting in the EU, and it follows the recent EU approval of Trodelvy monotherapy for PD-L1-negative patients. Together, these approvals make Trodelvy the backbone therapy for first-line metastatic TNBC across all PD-L1 statuses in Europe. The approval is based on the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed a 35% reduction in risk of disease progression or death. This expands Trodelvy's addressable market in a high-need cancer and strengthens Gilead's oncology franchise.
At the time of this announcement, GILD was trading at $146.80 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $181.2B. The 52-week trading range was $108.46 to $157.29. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.