Celgene Review Extended by the FDA

The Food and Drug Administration has decided to extend its review of the cancer-fighting drug Revlimid by three months, according to Celgene Corporation.

The FDA was expected to approve Revlimid this week for the treatment of myelodysplastic syndromes.

The review’s extension is a result of the FDA requiring more time to review additional information on Celgene’s RevAssist risk-management program. According to the company, the RevAssist program includes physician education, as well as interim pregnancy testing before and during treatment.

Revlimid is a derivative of thalidomide, a drug associated with birth defects, and the delay in approval for Revlimid is designed to satisfy the FDA that a fetus would not be exposed to the drug.

Celgene had already submitted animal studies that showed Revlimid’s structure and biology were different from thalidomide and did not cause birth defects in rats and rabbits.

Celgene has been marketing thalidomide under the product name Thalomid since 1998 for the treatment of leprosy. However, many physicians use it on an “off-label” basis to treat multiple myeloma, although it is not officially approved.

Thalomid has rigorous restrictions on its use, including frequent pregnancy testing of female patients, to protect fetuses from exposure. Celgene said that they are discussing a similar program for Revlimid with the FDA.