Revlimid is administered in combination with dexamethasone, an anti-inflammatory medicine, to treat adult patients with multiple myeloma whose disease has been treated at least once in the past.
The review of Revlimid was made after results of three new studies revealed a higher rate of new cancers in patients with newly diagnosed multiple myeloma. All patients were being treated with Revlimid and received other treatments concomitantly.
Researchers discovered a four-fold increase in the number of new cancers in patients being treated with Revlimid. The cancers included solid tumors and cancers of the blood and the immune system. Despite the fact that the studies were conducted in patients for whom Revlimid is not currently indicated, the Agency's Committee for Medicinal Products for Human Use (CHMP) raised concern regarding the result's relevance in the approved patient population.
They weighed the benefits of Revlimid against the risks in the approved patient population by reviewing all available data on new cancers in the approved population, including data from studies and post-marketing data. The study concluded that the risk of new cancers, such asskin cancers and some invasive solid tumors was observed in studies in the approved population. Investigators of the Committee also reviewed available data from the three studies in newly diagnosed multiple myeloma patients and concluded that Revlimid's benefits, in particular improved survival, continues to outweigh the risks. However, they recommend an update to Revlimid's prescribing information that should include a warning and advice to doctors on the risk of new cancers.
The Committee also reminds doctors that the current review of the benefits and risks of Revlimid only covers the approved patient population and does not cover its use outside of the current authorized indication. The Committee is now waiting for the European Commission to adopt their decision.
Written by: Petra Rattue
View drug information on Revlimid.
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