Breast Cancer Drug Approvals Issued by EMA: A Review of Clinical Trials

• Published in: Cancers Vol. 13; no. 20; p. 5198
• Main Authors: Duranti, Simona, Fabi, Alessandra, Filetti, Marco, Falcone, Rosa, Lombardi, Pasquale, Daniele, Gennaro, Franceschini, Gianluca, Carbognin, Luisa, Palazzo, Antonella, Garganese, Giorgia, Paris, Ida, Scambia, Giovanni, Pietragalla, Antonella
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 16.10.2021; MDPI
• Subjects: Breast cancer; Cancer therapies; Chemotherapy; Clinical trials; Drug development; Drugs; drugs approval; Ejection fraction; EMA; ErbB-2 protein; Medical prognosis; Metastases; Metastasis; Mortality; Pharmaceutical industry; Review; Reviews; Statistical analysis
• ISSN: 2072-6694; 2072-6694
• DOI: 10.3390/cancers13205198

Breast cancer represents the first cause of cancer worldwide and the leading cause of cancer mortality for women. Therefore, new therapies are needed to improve the prognosis of women diagnosed with this disease. In this review, we summarize the new drug indications for the treatment of breast cancer approved by European Medicines Agency between January 2015 and June 2021. In particular, we analyzed the clinical trials results leading to approvals and their update (when available), according to setting (localized and locally advanced or metastatic) and clinical features (hormone receptor positive, HER2 positive, triple negative, BRCA 1/2 mutation). The aim of this paper is to describe the clinical benefit obtained with the new indications.