REVLIMID is now indicated in relapsed or refractory mantle cell lymphoma (MCL)

18 Jun 2013 5:09 PM | Lori Aubrey (Administrator)

On June 5, 2013, the U. S. Food and Drug Administration approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.  

The approval was based a single-arm, multicenter clinical trial enrolling 134 patients with mantle cell lymphoma who have relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. All 134 patients received prior treatment with bortezomib and 60% were documented to have disease refractory to bortezomib therapy. Patients received a median of 4 prior therapies for MCL. The median age was 67 years, 81% were male, 96% were Caucasian, and 61% had MCL for at least 3 years.

http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm355438.htm

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Northern New England Clinical Oncology Society
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Sandown, NH 03873-0643
Telephone (603) 887-1948
info@nnecos.org

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