The oral blood-cancer drug Revlimid (lenalidomide) has received marketing approval from Health Canada to treat patients with multiple myeloma.
Authorisation is based on two phase III special protocol assessment trials – North American Trial MM-009 and International Trial MM-010.
These trials evaluated Revlimid 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 approved in the US, the EU, Argentina and Switzerland for myeloma, and in Australia for the treatment of patients whose disease has progressed after one therapy.
It is also approved in Canada, the US and Argentina for transfusion-dependent anaemia due to low or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Revlimid is an IMiDs compound, and continues to be evaluated in over 100 clinical trials in a broad range of haematological and oncological conditions.
The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.
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.
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