GILD · News · 20260824N
Oncology Product Expansion
GILEAD SCIENCES, INC. · 2026-08-24 · Importance 47 · Surprise 60 · In source text
The European Commission approved Trodelvy in combination with Merck’s Keytruda for first-line treatment of adults with PD-L1-positive, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) in Europe. Trodelvy was also approved as monotherapy for metastatic TNBC patients who are not candidates for PD-1/PD-L1 inhibitors, extending its use across PD-L1 status and treatment eligibility. The decision was based on the ASCENT-04/KEYNOTE-D19 study, which showed that the Trodelvy-Keytruda combination significantly reduced the risk of disease progression or death.
Key facts
- The EU approval of Trodelvy plus Keytruda was based on the ASCENT-04/KEYNOTE-D19 study, which showed Trodelvy plus Keytruda significantly reduced the risk of disease progression or death. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | committed | — | The EU approval of Trodelvy plus Keytruda was based on the ASCENT-04/KEYNOTE-D19 study, which showed Trodelvy plus Keytruda significantly… |