Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl (NASDAQ: CELG) announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

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 11,000 men and women in Japan currently undergoing treatment for multiple myeloma, and approximately 4,000 are newly diagnosed each year.

The approval of REVLIMID was based upon the safety and efficacy results of multiple pivotal randomized Phase III international trials in patients with multiple myeloma. The Phase I clinical results with Japanese patients, including those from MM-017, confirmed efficacy and further supported the approval.

RevMate™, a proprietary distribution program developed by Celgene, was also approved. REVLIMID will only be available to patients through this program.

Celgene will continue working with the Japanese regulatory authorities to determine the next steps for pricing and reimbursement.