EMA's CHMP backs Trodelvy monotherapy for first-line triple-negative breast cancer in Europe

The EMA's CHMP adopted a positive opinion recommending Trodelvy as a monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitors. The opinion rests on ASCENT-03, which showed a 38% lower risk of progression or death versus chemotherapy. A European Commission decision is expected later in 2026.

• CHMP positive opinion for Trodelvy monotherapy in first-line mTNBC
• Applies to patients who are not candidates for PD-1 or PD-L1 inhibitors
• ASCENT-03: 38% reduced risk of progression or death versus chemotherapy
• European Commission decision expected later in 2026