Drug Utilisation of Radium-223 Under Routine Clinical Practice (DIRECT) in Europe: A Post-Authorisation Safety Study.

ABSTRACT:

Introduction

Radium-223 is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases, without visceral metastases, who progress after at least (≥) two lines of or are ineligible for other systemic therapies (besides luteinising hormone-releasing hormone analogues). Radium-223 is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Point 2 and the contraindication above were added to the 2018 European Medicines Agency (EMA) label. In the observational cohort study reported here, we evaluated compliance with the 2018 revised label.

Methods

The proportion of patients with mCRPC who initiated radium-223 in the Netherlands, Germany and Denmark was analysed descriptively before (2013-2017) and

SUBMITTER: Weinrib R 

PROVIDER: S-EPMC12378252 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature