The Food and Drug Administration (FDA) has decided to extend its review of the cancer-fighting drug Revlimid, according to the drug’s developer, Celgene Corporation.
The FDA was expected to approve Revlimid this week for the treatment of a blood condition called myelodysplastic syndromes, or MDS. The federal agency announced its three-month delay to the company on Friday, September 30.
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.
According to Reuters, 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.
The news agency reported that 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’s spokesman, Brian Gill, said that until the FDA is 100% sure, it wants additional animal studies to confirm that the drug is significantly different from thalidomide.
Celgene has been marketing thalidomide under the product name Thalomid since 1998 for the treatment of consequences related to leprosy. However, according to Reuters, many physicians use it on an “off-label” basis to treat another blood cancer called multiple myeloma, although it is not officially approved to treat that condition.
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.