Summary of opinion: Trodelvy,sacituzumab govitecan, 22/06/2023, Positive
On 22 June 2023, 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 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:1
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1).
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 in the revised European public assessment report (EPAR), 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.
1New text in bold
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