The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer

ESMO Open

article

S. Michaleas¹  A. Moreno Oliver¹  J. Mueller-Berghaus²  S.B. Sarac³  M.E. van der Elst⁴  S. Müller-Egert²  H. Zander²  H. Enzmann⁶  F. Pignatti¹ 

[1] Oncology and Haematology Office, European Medicines Agency;Paul-Ehrlich-Institut;Danish Medicines Agency;College ter Beoordeling van Geneesmiddelen;Pharmacovigilance Risk Assessment Committee PRAC European Medicines Agency;Bundesinstitut für Arzneimittel und Medizinprodukte;Committee for Medicinal Products for Human Use ,(CHMP), European Medicines Agency

关键词: EMA;    TNBC;    sacituzumab govitecan;    ADC;    Trop-2;   

DOI  :  10.1016/j.esmoop.2022.100497

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Sacituzumab govitecan (SG) is an antineoplastic agent which combines a humanized monoclonal antibody binding to trophoblast cell surface antigen-2 (Trop-2)-expressing cancer cells, linked with cytotoxic moiety SN-38 (govitecan) with topoisomerase I inhibitor action. On 22 November 2021, a marketing authorization valid through the European Union (EU) was issued under the European Medicines Agency (EMA)'s accelerated assessment program for SG as monotherapy 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. The assessment was based on results from an open-label, randomized, phase III trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SG versus treatment of physician's choice (TPC) in patients with mTNBC who received at least two prior treatments including at least one of them for advanced disease. The efficacy results in the overall population, based on mature data, showed a statistically significant improvement of SG over TPC in progression-free survival (PFS) and overall survival (OS). The median PFS was 4.8 months versus 1.7 months [hazard ratio (HR) = 0.43, n = 529; 95% CI 0.35-0.54; P < 0.0001] and the median OS was 11.8 months versus 6.9 months (HR = 0.51, n = 529; 95% CI 0.41-0.62; P 30%) side effects of SG were diarrhea, neutropenia, nausea, fatigue, alopecia, anemia, constipation and vomiting. The aim of this manuscript is to summarize the scientific review of the application leading to regulatory approval in the EU.

【 授权许可】

CC BY|CC BY-NC-ND