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US drugmaker Celgene has been granted full approval by the European Commission to market its oral cancer drug Revlimid® (lenalidomide), an analogue of thalidomide.
The EC backed an earlier recommendation by the EMEA’s Committee for Medicinal Products for Human Use and gave the green light to Revlimid, in combination with dexamethasone, as a treatment for patients with multiple myeloma who have received at least one prior therapy.
The approval is clearly a boost for Celgene, as Revlimid is the first medicine sold by the company cleared for use in Europe.
The firm said the drug represents the first breakthrough oral cancer therapy for multiple myeloma patients in more than 40 years. Professor Gareth Morgan, head of haematology at the Royal Marsden Hospital in London, UK, said the approval of Revlimid is good news for both physicians and patients.
He said it has been shown to more than double time to disease progression, “improves survival by almost one year and has the added benefit of convenient oral dosing”.
The news was welcomed by the International Myeloma Foundation. Chairman Brian Durie said: “Until we have a cure for multiple myeloma we need a strong arsenal of drugs that we can use in combination and in sequence to maintain remission, and Revlimid is a powerful addition to that arsenal.
“In fact, it is so powerful that we are now considering medical options for newly diagnosed patients, in place of costly and debilitating bone marrow transplants that until now have been a standard of care.”
Multiple myeloma is the second most commonly diagnosed blood cancer and there are an estimated 750,000 people with the disease worldwide. In the UK, it causes some 2,500 deaths a year and at any one time there will be just fewer than 8,000 patients with the condition. Mortality is high: 45% of patients die in the first year and 80% within five years. Revlimid has been approved in the USA (along with a steroid) for previously-treated myeloma patients since June 2006.