FDA requests more information from Celgene

Although Thalomid is already prescribed off-label by doctors wishing to treat multiple myeloma (progressive blood cancer), Celgene is intent on acquiring official recognition for the indication.

In response to the company’s application, the FDA issued an approvable letter requesting revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review.

Celgene’s application for Thalomid is based on results from a large phase III randomized study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients.

“Based on ongoing discussions with the FDA we expect to complete our responses to these requests quickly,” said Dr Graham Burton, senior vice president for regulatory affairs and pharmacovigilance at Celgene.