REVLIMID approved in Canada
Celgene announced that its oral cancer drug REVLIMID (lenalidomide) 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. Multiple myeloma is the second most commonly diagnosed blood cancer worldwide.
Approximately 6,000 Canadians have the disease and another 2,000 are diagnosed each year.
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--both published in the New England Journal of Medicine in November 2007.
REVLIMID is currently approved in the United States, the European Union, 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. REVLIMID is also approved in Canada, the United States and Argentina for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland and Australia.
Approximately 6,000 Canadians have the disease and another 2,000 are diagnosed each year.
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--both published in the New England Journal of Medicine in November 2007.
REVLIMID is currently approved in the United States, the European Union, 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. REVLIMID is also approved in Canada, the United States and Argentina for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland and Australia.
posted by gwg at 5:43 PM
1 Comments:
Lenalidomide is a drug that is very similar to thalidomide, which is known to cause severe birth defects or death in unborn babies. For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Revlimid Education and Prescribing Safety Program, developed by the U.S. Food and Drug Administration.
-------------
Sally
Promoter
Post a Comment
<< Home