Celgene pulls EU Revlimid application as CHMP seeks follow-up cancer data

Celgene has withdrawn its European application to have its blood cancer drug Revlimid (lenalidomide) approved for maintenance use in newly diagnosed patients with multiple myeloma –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.