Gilead's Trodelvy Secures CHMP Nod for First-Line Metastatic TNBC in Europe

Event summary

  • CHMP recommends marketing authorization for Trodelvy in first-line metastatic TNBC for patients ineligible for PD-(L)1 inhibitors.
  • European Commission decision expected later in 2026.
  • Phase 3 ASCENT-03 study showed 38% reduced risk of disease progression or death.
  • Trodelvy is already approved in over 60 countries for second-line TNBC and pre-treated HR+/HER2- metastatic breast cancer.
  • Gilead also submitted applications for Trodelvy plus Keytruda in PD-L1 positive TNBC.

The big picture

Gilead's Trodelvy is poised to become a cornerstone therapy for first-line metastatic TNBC in Europe, addressing a critical unmet need for patients ineligible for PD-(L)1 inhibitors. The CHMP's positive opinion underscores the drug's clinical efficacy and could pave the way for broader adoption in a highly aggressive cancer subtype. With ongoing trials and regulatory submissions, Gilead is positioning Trodelvy as a key player in the evolving landscape of breast cancer treatments.

What we're watching

Regulatory Timelines
Whether the European Commission will approve Trodelvy for this new indication by the end of 2026.
Commercial Strategy
How Gilead positions Trodelvy as a backbone treatment in first-line metastatic TNBC across PD-L1 status.
Competitive Dynamics
The pace at which Gilead can expand Trodelvy's use in combination therapies, particularly with Keytruda.