Celgene pulls EU Revlimid application as CHMP seeks follow-up cancer data
This article was originally published in Scrip
Executive Summary
Celgene has withdrawn its European application to have its blood cancer drug Revlimid (lenalidomide) approved for maintenance use in newly diagnosed patients with multiple myeloma – an expanded use - after EU regulators made it clear that additional follow-up was needed from three ongoing studies in the submission with respect to the treatment's links to second primary malignancies. They claim they need this mature data to make a clear benefit-risk decision.
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