Celgene Corp. (CELG: Quote) announced that it has received approval from the U.S. Food and Drug Administration or FDA for its supplemental new drug application or sNDA for REVLIMID for the treatment of patients with mantle cell lymphoma or MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
The company stated that the approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline, and bortezomib alone or in combination.
Patients were required to have documented refractory disease which is defined as without any response of partial response or better during treatment with bortezomib or a bortezomib-containing regimen, or relapsed disease - defined as progression within one year after treatment with bortezomib or a bortezomib-containing regimen, Celgene said.
Patients with a creatinine clearance were given lenalidomide at 25mg once daily for 21 days every 28 days. Patients with a creatinine clearance were given lenalidomide at a dose of 10mg once daily for 21 days every 28 days.
REVLIMID is an analogue of thalidomide, is contraindicated in pregnancy, and if used during pregnancy may cause birth defects or embryo-fetal death. It is only available through a restricted distribution program called REVLIMID REMS™. Revlimid can cause significant neutropenia and thrombocytopenia. Deep vein thrombosis and pulmonary embolism occur in patients who have been treated with REVLIMID, the company noted.
Allergic reactions, including fatalities, comprising hypersensitivity, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis have been reported in patients treated with REVLIMID.
Also, serious tumor flare reactions have occurred during investigational use of REVLIMID for chronic lymphocytic leukemia and lymphoma. Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID in combination with dexamethasone.
by RTT Staff Writer
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