Celgene’s Revlimid Recommended by ADEC

Celgene International’s oral cancer drug Revlimid has received a recommendation for approval from the Australian Drug Evaluation Committee (ADEC) for use in combination with dexamethasone as a treatment for multiple myeloma.

The recommendation will be forwarded to the Therapeutic Goods Administration (TGA) for ratification. The TGA grants marketing approval after the final prescribing information is negotiated and certificates of registration are issued.

The recommendation for Revlimid’s (lenalidomide) approval was based on the results of two randomized Phase III trials, Celgene said.

Revlimid is approved in the U.S., the European Union and Switzerland.