Celgene International Sàrl announced that its oral cancer drug, Revlimid (lenalidomide) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

This approval represents the first regulatory approval for Celgene in Switzerland, and Revlimid represents the first oral therapy in Switzerland for multiple myeloma patients in more than forty years. Revlimid is currently approved by the US Food and Drug Administration (FDA) under 21 CFR 314.500, Acclerated Approval of New Drugs for Serious or Life-Threatening Illnesses.

Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are more than 85,000 men and women in Europe currently undergoing treatment for multiple myeloma, and 25,000 people are expected to die from this blood cancer in 2007.

Celgene International is working diligently with Swissmedic to determine next steps for pricing, reimbursement and distribution so that Revlimid is available for eligible patients in Switzerland as quickly as possible.

The Marketing Authorization Application (MAA) for Revlimid was based upon the safety and efficacy results of two large, randomized pivotal phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating Revlimid plus dexamethasone in multiple myeloma patients that have received at least one prior therapy.

Celgene remains committed to the broad and global clinical development of other investigational therapies being studied in blood and solid tumour cancers.

Revlimid has obtained Orphan Drug designation in the EU, US and Australia for treatment of multiple myeloma. Revlimid is approved for use as an oral treatment in combination with dexamethasone by the European Commission, following the recommendation from the European Medicines Agency (EMEA). Revlimid is currently approved in the US by the US Food and Drug Administration (FDA) for multiple myeloma patients who have received at least one prior therapy. Revlimid is also approved in the US, for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and subject to a restricted distribution program named RevAssist.