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Revlimid: EMA concludes benefit-risk balance still positive

Added: Wednesday 2 November 2011

The European Medicines Agency has confirmed that the benefit-risk balance for Revlimid (lenalidomide) remains positive within its approved patient population, but advises doctors of the risk of new cancers as a result of treatment with the medicine. Studies had been carried out among patients for whom Revlimid is not currently indicated and showed a four-fold increase in cancers in this patients. The Committee concluded that the benefits continue to outweigh the risks but reminded doctors that the current risk-benefit assessment only covers the approved patient population.