The EMA has concluded that the benefit-risk balance for Revlimid (lenalidomide) remains positive, despite studies highlighting a link with the occurrence of new cancers.
A review by the CHMP analysed data in the approved population and concluded there was a link with fresh cancers developing but its improved survival benefits continue to outweigh any risk.
Recommendations have now been made by the Committee to update the prescribing information and a “warning and advice” given to clinicians on the risk of new cancers.
Revlimid is used in combination with dexamethasone to treat adults with multiple myeloma whose disease has been treated at least once in the past. It was authorised in the EU in 2007.
But concerns were raised by the CHMP after three new studies were carried out in patients for whom the medication is not indicated. These found a higher rate of new cancers in newly diagnosed patients being treated with Revlimid and other treatments concomitantly.
The trio of studies found a four-fold increase in the number of new cancers in patients and the Committee decided to investigate if the results could be relevant for the approved patient population.
All available data was analysed by the Committee during the review who observed a risk of skin cancers and invasive solid tumours developing in patients using the treatment. However, the CHMP says its benefits are still greater than any associated risks.
Revlimid was previously sent for reviewin March 2011 following reports that lenalidomide may be associated with an increased risk of second primary malignancies.
The CHMP’s opinion has now been forwarded to the European Commission for the adoption of a decision.