• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

News & Events

  • Print
  • Share
  • E-mail

Section Contents Menu

Newsroom

FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-114
December 28, 2005

Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Approves New Treatment for Myelodysplastic Syndrome (MDS)

The Food and Drug Administration (FDA) has approved the drug Revlimid (lenalidomide) for the treatment of patients with a subtype of Myelodysplastic Syndrome (MDS). The subtype is MDS patients with deletion 5q cytogenetic abnormality.

MDS is a collection of disorders in which the bone marrow does not function normally and the body does not make enough normal blood cells. Patients with MDS may need blood and platelet transfusions and antibiotic therapy for infections. In clinical trials, patients treated with Revlimid no longer needed transfusions, with most patients becoming independent of transfusion by three months. The transfusion-free period lasted for an average of 44 weeks.

"This new product will offer a much needed treatment option for patients suffering from this rare illness that, in some cases, has been found to progress to fatal forms of leukemia," said Dr. Steven Galson, M.D., Director of FDA's Center for Drug Evaluation and Research (CDER).

MDS can develop following treatment with drugs or radiation therapy for other diseases, or it can develop without any known cause. Some forms of MDS can progress to acute myeloid leukemia (AML), a type of cancer in which too many white blood cells are made.

An estimated 7,000 to12,000 new cases of MDS are diagnosed yearly in the United States. Although MDS occurs in all age groups, the highest prevalence is in people over 60 years of age. Typical symptoms include weakness, fatigue, infections, easy bruising, bleeding, and fever

Revlimid is structurally similarto thalidomide, a drug known to cause severe birth defects. Additional studies are ongoing in animals to address whether there is a risk that Revlimid will also cause birth defects when taken during pregnancy. While these studies are under way, the company is marketing Revlimid under a risk management plan called RevAssist, designed to prevent fetal exposure.

Under RevAssist, only pharmacists and prescribers registered with the program will prescribe and dispense Revlimid. The program requires patients, including female patients undergoing mandatory pregnancy testing, to give informed consent before starting Revlimid. Physicians are to check pregnancy tests, limit prescriptions to a one-month mail supply, and report any pregnancies to FDA. FDA and the manufacturer will re-evaluate the risk management plan when results of further animal testing for birth defects are completed.

The labeling for Revlimid will include a Black Box Warning and a Medication Guide regarding the prevention of fetal exposure. Additional Black Box Warnings include the potential need to lower the dose due to suppressed blood counts and increased risk of blood clots. Common side effects reported with Revlimid include thrombocytopenia (low platelet count), neutropenia (low white blood cell count), diarrhea, pruritis (itch), rash, and fatigue.

Revlimid is distributed by Celgene Corporation of Summit, N.J.

#
 

RSS Feed for FDA News Releases [what is RSS?]