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

Simona Duranti; Alessandra Fabi; Marco Filetti; Rosa Falcone; Pasquale Lombardi; Gennaro Daniele; Gianluca Franceschini; Luisa Carbognin; Antonella Palazzo; Giorgia Garganese; Ida Paris; Giovanni Scambia; Antonella Pietragalla

doi:10.3390/cancers13205198

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

Cancers (Basel). 2021 Oct 16;13(20):5198. doi: 10.3390/cancers13205198.

Authors

Simona Duranti¹, Alessandra Fabi^{1

2}, Marco Filetti³, Rosa Falcone³, Pasquale Lombardi³, Gennaro Daniele^{1

3}, Gianluca Franceschini⁴, Luisa Carbognin⁵, Antonella Palazzo⁶, Giorgia Garganese^{7

8}, Ida Paris⁵, Giovanni Scambia^{1

8}, Antonella Pietragalla¹

Affiliations

¹ Scientific Directorate, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
² Unit of Precision Medicine in Breast Cancer, Scientific Directorate, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
³ Phase 1 Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
⁴ Multidisciplinary Breast Center, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
⁵ Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
⁶ Comprehensive Cancer Center, UOC di Oncologia Medica, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
⁷ Gynecology and Breast Care Center, Mater Olbia Hospital, 07026 Olbia, Italy.
⁸ Department of Life Science and Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.

Abstract

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.

Keywords: EMA; breast cancer; drugs approval.

Publication types

Review