Istodax romidepsin regulatory update

EMA's CHMP recommended against approval of Istodax to treat peripheral T cell lymphoma (PTCL) in patients who have received >=2 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. ...