October 6, 2008
Celgene Wins Marketing Approval for Oral Myeloma Drug in Canada
Celgene International, a wholly owned subsidiary of Celgene Corporation, has announced that its oral cancer drug Revlimid has received marketing authorization approval from Health Canada for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.
The authorization from Health Canada 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 who have received at least one prior therapy.
Revlimid is currently approved in the US, the EU, Argentina and Switzerland in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy.
Kevin Leshuk, general manager at Celgene Canada, said: "Health Canada's authorization of Revlimid represents a significant new option for multiple myeloma patients in this country. This continues our stated goal of delivering Revlimid as a safe, effective oral therapy to patients worldwide as quickly as possible."