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Revlimid® Approved by the FDA

Jan. 2006

Celgene Corporation's Revlimid® (lenolidomide) has been approved by the U. S. Food & Drug Administration (FDA) for patients with a subgroup of myelodysplastic syndromes (MDS). Revlimid® was given priority review and fast track status by the FDA. It is an oral medication approved for the treatment of low- or intermediate-risk MDS associated with deletion of 5q, a chromosomal (cytogenetic) abnormality, with or without other Cytogenetic abnormalities.

“The clinical data from a Phase II trial of 148 patients demonstrated that Revlimid can reduce or even eliminate the need for transfusions in many patients with del 5q MDS," said Dr. Alan List, Professor of Oncology and Medicine, and Chief Division of Hematologic Malignancies Hematologic Malignancies at H. Lee Moffitt Cancer Center, Tampa, Florida, and the study's lead investigator. "I am extremely pleased with the FDA's action today."

Revlimid® is a member of a new class of drugs called immunomodulatory Drugs (IMiDs), drugs that can modify or regulate the functioning of the Immune system. IMiDs are a group of oral drugs that are chemically similar to thalidomide.

Revlimid® is expected to be available for distribution in early 2006. Since Revlimid® is chemically similar to Thalidomid® (thalidomide), it may cause severe birth defects. To ensure the safety of patients the FDA has required Celgene Corporation to market Revlimid® with a Black Box warning, and under a risk management program (a special, restricted distribution program) called RevAssist.

RevAssist is designed to educate patients, their physicians and pharmacists about the possible side effects. The FDA approved goals of RevAssist are as follows: 1)Prevent fetal exposure to Revlimid® by registering and educating all physicians, pharmacists and patients and monitoring pregnancy prevention activities. 2)Reduce the risk of fetal exposure from males taking Revlimid® who engage insexual contact with a female partner of child bearing potential. 3)Educate physicians, other healthcare providers, and patients about potential lowering in blood cell counts (cytopenias) associated with Revlimid® therapy.

Prescriptions of Revlimid® will be limited to a 28 day supply, only distributed to patients of registered and RevAssist educated physicians, and filled by specialty pharmacies. For more information about RevAssist please visit a www.revlimid.com, or call (888) 4Celgene, or call the AA & MDSIF Information Specialists (800) 747-2820.