Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for continuous oral treatment with Revlimid in adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.

The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but deadly disease: around 38,900 people were newly diagnosed with multiple myeloma in Europe in 2012, and 24,300 people died from the disease in the same year.  On average, multiple myeloma is diagnosed between 65-74 years of age.  The majority of newly diagnosed patients are not eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant, and there is currently no therapy option approved for continuous treatment to help manage the disease over the long term. 

"When recommending a therapy at first diagnosis, our aim is to keep the disease under control for as long as possible," says Professor Thierry Facon, Services des Maladies du Sang, Hôpital Claude Huriez, and CHRU Lille, France. "The positive opinion for Revlimid for the continuous treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant is a significant step towards bringing a new therapy that could extend the time patients live without their disease progressing."

The anticipated European Commission decision would be the latest milestone for Celgene's flagship product in Europe and its continued focus on delivering innovative medicines for rare haematological diseases. Revlimid is already indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Revlimid is also indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

For more details, go to: http://ir.celgene.com/releasedetail.cfm?ReleaseID=888476