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

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Article number5198
Issue number20
Publication statusPublished - Oct 1 2021


  • Breast cancer
  • Drugs approval
  • EMA

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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