CHMP: mature OS data needed for Revlimid label expansion

EMA's CHMP reiterated on Wednesday that it needs mature overall survival data before it can make a decision on whether to approve an expanded label for multiple myeloma (MM) drug Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG). CHMP made the comments in a benefit-risk assessment report for a withdrawn application that had sought approval of Revlimid as maintenance treatment in newly diagnosed patients who have not progressed following initial treatment or following autologous stem cell transplantation.

The committee said the drug's lack of an OS advantage in clinical trials in the indication "considerably limits the relevance" of its progression-free survival (PFS) advantage, which the committee called "impressive." CHMP expressed concern about the risk of secondary malignancies, but noted that the risk would be acceptable if Revlimid showed a clear survival benefit. CHMP added that the "neutral" OS effect may reflect that maintenance treatment and treatment at progression have equivalent efficacy, or that Revlimid has a negative effect on cancer risk, both of which the committee said would favor delaying Revlimid treatment. ...