Novel breast cancer drug gains approval in European Union

21 September 2023

Italian drugmaker Menarini has secured European approval for Orserdu (elacestrant) as a monotherapy for the treatment of certain people with advanced or metastatic breast cancer.

The decision was made based on data from the Phase III EMERALD trial, which showed a positive treatment effect for people with estrogen receptor–positive, HER2-negative cancer.

The approval covers patients who have disease progression following at least one line of endocrine therapy, including a CDK 4/6 blocker.

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