External Independent Data Monitoring Committee (IDMC) analyses of both phase III trials exceeded the pre-specified value for stopping the trials, as the IDMC found a statistically significant improvement in time to disease progression in patients receiving Revlimid plus dexamethasone, compared to patients receiving dexamethasone alone.
Celgene has initiated discussions with the FDA and international regulatory authorities regarding the submission of this data for potential approval. Treatment assignments for patients currently on the trials will be unblinded and those currently not on Revlimid will now have the opportunity to add Revlimid to their dexamethasone regimen.
“Following preliminary analysis we plan to use this data as the basis of a regulatory submission to the FDA and international regulatory agencies for Revlimid in previously treated multiple myeloma patients,” said Dr Jerome Zeldis, chief medical officer and vice-president of medical affairs at Celgene.
In addition to the initial positive efficacy profile, the preliminary safety profile was favorable. All data are being analyzed further for the regulatory submissions.