CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic breast cancer

If authorised, the combination would add an antibody-drug conjugate-based first-line option for eligible European patients with unresectable locally advanced or metastatic triple-negative breast cancer. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended extending Trodelvy’s marketing authorisation to include its use with Keytruda in adults with previously untreated, PD-L1-positive, unresectable locally advanced or metastatic triple-negative breast cancer. The positive opinion could expand first-line treatment choice for this population, but a European Commission decision is still required before the indication is authorised in the EU.

Field	Content
Alert Type	Industry Update
Topic	Regulatory recommendation and first-line breast cancer treatment
Organisation(s)	European Medicines Agency; Committee for Medicinal Products for Human Use; Gilead Sciences
Affected Stakeholders	Medical oncologists, eligible patients with metastatic triple-negative breast cancer, Gilead Sciences, Merck, payers and national reimbursement authorities
Therapy Area(s)	Oncology; breast cancer
Geography	European Union
What Happened	On 24 July 2026, the CHMP adopted a positive opinion recommending Trodelvy (sacituzumab govitecan) in combination with Keytruda (pembrolizumab) for adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours express PD-L1 with a combined positive score of at least 10 and who have not received systemic treatment for metastatic disease. The opinion is a regulatory recommendation rather than a marketing authorisation and will now be considered by the European Commission.
Why It Matters	If authorised, the regimen would provide an antibody-drug conjugate plus immunotherapy option in the first-line PD-L1-positive setting. The recommendation also extends Trodelvy’s potential role across first-line metastatic triple-negative breast cancer, following EU authorisation of Trodelvy monotherapy for patients who are not candidates for PD-1 or PD-L1 inhibitor treatment.
Supporting Context	The recommendation is based on the Phase 3 ASCENT-04/KEYNOTE-D19 study, in which Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% compared with standard chemotherapy plus Keytruda in patients with PD-L1-positive metastatic triple-negative breast cancer.
Who Is Most Affected	Oncologists and eligible patients would be most directly affected by the possible addition of a new first-line regimen. Payers and health technology assessment bodies would subsequently assess pricing, reimbursement and positioning within European treatment pathways.
Industry Impact	Authorisation could increase competition in the first-line metastatic triple-negative breast cancer market and support wider use of antibody-drug conjugates earlier in treatment. The practical impact would depend on the final European Commission decision, national reimbursement and clinical adoption.
Key Takeaway	The CHMP opinion moves Trodelvy plus Keytruda closer to becoming a first-line European treatment option for PD-L1-positive metastatic triple-negative breast cancer, but the combination is not yet authorised for this indication.
What to Watch	The European Commission’s final decision, the authorised label and subsequent pricing and reimbursement decisions across individual EU Member States.
Primary Source	European Medicines Agency opinion on the Trodelvy variation
Relevant Date	24 July 2026 — CHMP positive opinion

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