Summary of opinion: Trodelvy, 21/05/2026 Positive
Summary of opinion: Trodelvy, 21/05/2026 Positive
Opinion
On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trodelvy. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland Unlimited Company.
The CHMP adopted a new indication as follows:
Trodelvy is indicated:
- as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1).
For information, the full indications for Trodelvy will be as follows:
Triple-Negative Breast Cancer
Trodelvy is indicated:
- as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1).
- as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1)
HR-Positive, HER2-Negative Breast Cancer
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold, removed text as strikethrough.
CHMP post-authorisation summary of positive opinion for Trodelvy (VR-0000312649)
Adopted
Reference Number:
EMADOC-1700519818-3129523
English (EN) (127.9 KB - PDF)
First published:
22/05/2026
View
Key facts
Name of medicine
Trodelvy
EMA product number
EMEA/H/C/005182
Active substance
sacituzumab govitecan
International non-proprietary name (INN) or common name
sacituzumab govitecan
Therapeutic area (MeSH)
- Breast Neoplasms
- Triple Negative Breast Neoplasms
Anatomical therapeutical chemical (ATC) code
L01FX06
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Marketing authorisation holder
Gilead Sciences Ireland UC
Date of opinion
21/05/2026
Status
Positive
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More information on Trodelvy
This page was last updated on
22/05/2026
Summary
On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trodelvy. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland Unlimited Company. The CHMP adopted a new indication as follows: Trodelvy is indicated: as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). For information, the full indications for Trodelvy will be as follows: Triple-Negative Breast Cancer Trodelvy is indicated: as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1). Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. Note: New text in bold, removed text as strikethrough.