US drugmaker Celgene Corp has been granted full approval by the European Commission to market its oral cancer drug Revlimid, an analogue of thalidomide.
The EC has backed an earlier recommendation by the European Medicine Agency's Committee for Medicinal Products for Human Use and given the green light to Revlimid (lenalidomide), 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. It said that the drug represents the first breakthrough oral cancer therapy for multiple myeloma patients in more than 40 years and Gareth Morgan, professor of haematology at the Royal Marsden Hospital in Surrey, UK, said the approval of Revlimid is good news for both physicians and patients. He added that 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
and its chairman Brian Durie said that “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". He added that “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 approximately 2,500 deaths each year and at any one time there will be just fewer than 8,000 patients with the condition. Mortality is high with 45% of patients dying 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