ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate, nal-IRI) in combination with 5-fluorouracil and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas in patients who have progressed following gemcitabine based therapy received a marketing authorization from The European Commission. The agent is sponsored by Shire. Wth this approval, Shire is authorized to market Onivyde in...
Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients.
