Celgene receives CHMP backing for new Revlimid indication

Celgene has announced that its cancer drug Revlimid has been recommended for European regulatory approval in a new indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the use of Revlimid as a monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Data from two phase III studies showed that the drug was able to significantly reduce the risk of disease progression or death in patients with multiple myeloma. Both trials were unblinded after passing their pre-specified boundary for superiority at interim analysis.

If approved by the European Commission, the drug will become the first and only licensed maintenance treatment available to these patients.

Tuomo Patsi, president of Celgene in Europe, the Middle East and Africa, said: "We aspire to turn some of the most challenging diseases, like multiple myeloma, into manageable conditions. Therefore, we will continue to invest more than one-third of our revenues back into research and development."

A final decision from the European Commission is expected in approximately two months.

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