Vidaza azacitidine regulatory update

A NICE appeals panel said the U.K. agency should reappraise Vidaza azacitidine from Celgene because its original appraisal against NHS use of the cancer drug only included 1 of 2 possible comparators. The panel asserted there was "no reason" to exclude chemotherapy as a comparator because of its wide use and recommended the reappraisal include both best supportive care and chemotherapy as comparators. Celgene's original submission to NICE included data from the Phase III AZA-001 trial, in which 41% of patients received chemotherapy. The appeals panel also requested that NICE consider additional quality of life data from the MDS UK Patient Support Group. ...