Gilead wins CHMP backing after 35% risk reduction
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- The CHMP recommended Trodelvy plus Keytruda for certain patients with previously untreated metastatic triple-negative breast cancer.
- Gilead shares were up 0.4% at $130.86 following the announcement.
- Gilead expects a European Commission decision on the proposed indication later in 2026.
Gilead Sciences (NASDAQ:GILD) received CHMP backing for Trodelvy plus Keytruda after the regimen reduced progression or death risk by 35%.
ASCENT-04 showed median progression-free survival of 11.2 months, compared with 7.8 months for chemotherapy plus Keytruda.
“People with metastatic TNBC desperately need new options as early as possible,” said Gilead Senior Vice President Mika Kakefuda Derynck.
The recommendation covers untreated metastatic TNBC with PD-L1 CPS ≥10, while the European Commission’s decision is expected later in 2026.
Following the announcement, Gilead's share price was up 0.4% at $130.86 as investors awaited the European Commission’s decision.
The European Commission approved Trodelvy monotherapy in June 2026 for first-line patients who cannot receive PD-1 or PD-L1 inhibitors.
The FDA also approved Trodelvy alone or with Keytruda in June 2026, expanding Gilead’s first-line metastatic TNBC indications.
