BioCentury
ARTICLE | Clinical News

Istodax romidepsin regulatory update

December 3, 2012 8:00 AM UTC

EMA's CHMP confirmed its negative opinion against approval of Istodax romidepsin from Celgene to treat peripheral T cell lymphoma (PTCL) in patients who have received >=2 prior therapies. The company requested a re-examination of the committee's July negative opinion, in which the CHMP 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 (see BioCentury, July 23). ...