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Revlimid (lenalidomide)

Company: Celgene
Approval Status: Approved December 2005
Treatment for: Myelodysplastic Syndromes
Areas: Hematology

General Information

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Revlimid (lenalidomide) is an orally available thalidomide analog, exerting both anti-angiogenic and immunomodulatory/anti-inflammatory properties.

Revlimid is specifically indicated for the treatment of patients with transfusion dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Revlimid is supplied as an opaque capsule for oral administration. Recommended dosing is 10 mg daily with water. Dosing may be reduced (to 5 mg once daily or once every other day) or temporarily suspended if incidence of thrombocytopenia or neutropenia is observed (see Side Effects, below).

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Clinical Results

FDA Approval
Approval of Revlimid was based on results of an open-label, single arm, multi-center study that enrolled 148 patients with red-blood-cell-transfusion dependent anemia due to low-or intermediate-1- risk MDS associated with a 5 q (q31-33) cytogenetic abnormality in isolation or with additional cytogenetic abnormalities. Subjects received 10 mg Revlimid once daily either continuously or for 21 of every 28 days. Sequential dose reductions, to 5 mg daily and 5 mg every other day, were permitted to mitigate toxicities. The drug was shown to be efficacious in reducing the need for red-blood cell transfusions: 67% (n=99/148) of patients experienced a period of at least 8 weeks during which no transfusion was needed, and the median duration of transfusion independence was maintained for a median 44 weeks. 90% of responders experienced onset of transfusion independence within 3 months. Dose interruption or reduction due to toxicity was necessary in 79.7% of patients (n=118/148).

Ongoing Study Commitments

The embryo-fetal toxicity assessment of Revlimid has not been adequately addressed. Celgene has agreed to provide adequate information for this assessment in appropriate models designed to fully assess the possible toxicity of Revlimid. Celgene plans to conduct these studies in two different species that are appropriate to assess the full range of thalidomide embryo-fetal effects. As discussed, the rat is not an acceptable model. If the study with lenalidomide in the first species shows clear evidence of teratogenesis, than a confirmatory study will not be necessary. Although not generally considered definitive test systems for pharmaceutical products, additional studies of an exploratory nature on the embryo-fetal effects of lenalidomide may be useful.
Protocol Submission: June 2006
Study Start: September 2006
Final Report Submission: December 2007
Celgene has agreed to submit the study report and data from the ongoing study, CC-5013-MDS-004, a randomized, double-blind, placebo-controlled, multicenter, 3-arm study of the efficacy and safety of 2 doses of lenalidomide (5 mg daily versus 10 mg day 21 days of a 28 day cycle) versus placebo in red blood cell (RBC) transfusion-dependent patients with low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality when completed.
Protocol Submission: March 2005
Study Start: August 2005
Final Report Submission: December 2008

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