Regulators in Europe have followed the example of their counterparts across the Atlantic and expanded approval on Celgene’s big-selling multiple myeloma drug Revlimid to include newly-diagnosed patients.
The European Commission has approved Revlimid (lenalidomide) for adults with previously untreated MM who are not eligible for transplant. It is currently marketed in combination with dexamethasone for patients who have received at least one prior therapy.
The EC decision comes a couple of days after a similar expanded approval was granted by the US Food and Drug Administration. They are certain to boost Revlimid’s already-impressive sales – fourth-quarter revenues reached $1.32 billion, up 16%.
Thierry Facon of the Claude Huriez hospital in Lille, France, said that the expanded approval “is a real step forward”, noting that “treating patients continuously until disease progression is supported by several clinical studies, and will have an important impact on how we manage the disease over the long-term”.
Tuomo Pätsi, president of Celgene in Europe, the Middle East and Africa, said that “we have seen significant progress in the treatment of the disease over the years, with an improvement of more than 50% in five-year survival rates”. However, “there continues to be a need for innovative new approaches to turn deadly diseases, like this one, into manageable, long-term, chronic conditions,” he added.
