EMA committee rebuffs Celgene's Istodax for PTCL

EMA's CHMP recommended against approval of Istodax romidepsin from Celgene Corp. (NASDAQ:CELG) to treat peripheral T cell lymphoma in patients who have received at least two prior therapies. The committee said the data in the application did not include comparators and therefore the committee could not evaluate the product's effect on overall survival (OS) and progression-free survival (PFS) compared with current PTCL treatments. Celgene said it will request a reexamination. Celgene was down $1.56 to $66.42 on Friday. ...