Photo courtesy of Celgene
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for lenalidomide (Revlimid®).
The CHMP advised the European Commission (EC) to approve the use of lenalidomide as maintenance therapy in adults who had newly diagnosed multiple myeloma (MM) prior to receiving an autologous stem cell transplant (ASCT).
If approved by the EC, lenalidomide will be the first licensed maintenance treatment available to this patient population in the European Union.
The EC, which generally follows the CHMP’s recommendations, is expected to make its final decision on this use of lenalidomide in approximately 2 months.
If approval is granted, detailed conditions for the use of lenalidomide will be described in the Summary of Product Characteristics, which will be published in the revised European Public Assessment Report.
Lenalidomide is a product of Celgene.
The CHMP’s recommendation to approve lenalidomide as maintenance in MM was based on the results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211. Results from both studies were published in NEJM in May 2012.
CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing ASCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.
IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen post-ASCT of lenalidomide monotherapy, followed by continuous daily treatment with lenalidomide or placebo until relapse.
“Studies show that maintenance treatment after ASCT with Revlimid may help control residual malignant cells and delay tumor growth by enhancing immune function,” said Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud in France.
“Our primary goal is to delay disease progression for as long as possible, and we have seen in several independent studies that Revlimid maintenance after ASCT can halve the risk of disease progression by sustaining the response.”
