Blow For Celgene As Revlimid Trial Miss Removes Blockbuster Indication

Celgene Corp.'s hopes of extending the market reach of its blockbuster oncology therapy Revlimid (lenalidomide) have taken a blow as Phase III data for the drug in elderly diffuse large B-cell lymphoma (DLBCL) patients have failed to show benefit on overall survival.

Dart board

The highly anticipated REMARC trial – which evaluated maintenance therapy with Revlimid compared with placebo in elderly DLBCL patients responding to first-line rituximab plus CHOP chemotherapy (R-CHOP) induction therapy – achieved its primary endpoint of a significant improvement in progression-free survival, but an interim analysis of overall survival data produced disappointing results for Celgene Corp. and its partner the Lymphoma Academic Research Organisation (LYSARC).

Lifecycle management of its leading oncology drug is a current priority for Celgene but as a result of Revlimid's failure to show a positive effect on overall survival, the big biotech will not to pursue approval for its cancer therapy in this DLBCL population

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