On 22 June 2023, the European Medicines Agency’s (EMA’s) 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 sacituzumab govitecan (Trodelvy).
The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.
The CHMP adopted a new indication for the treatment of hormone receptor (HR)-positive, HER2-negative breast cancer.
For information, the full indications for Trodelvy will be as follows (new indication in bold):
- Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, including at least one of them for advanced disease.
- Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.