EU-Wide Restrictions In Store For Bayer's Prostate Cancer Drug

Several medicines referred to the European Medicines Agency on issues relating to safety or benefit-risk profile are being discussed by the agency's medicines evaluation committee, the CHMP, this week.

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PRAC Had Recommended Restricting Xofigo's Use After Reviewing Safety Data • Source: Shutterstock

The European Medicines Agency's drug evaluation committee, the CHMP, is set to adopt final recommendations on restricting the EU-wide use of Bayer's prostate cancer medicine Xofigo. The CHMP is also expected to discuss several other medicines referred to the EMA for resolution of issues relating to their safety or benefit-risk balance.

The recommendations in relation to Xofigo (radium-223 dichloride) were issued earlier this month by the EMA's pharmacovigilance committee, the PRAC,...

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