The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorization of Onivyde (irinotecan liposome injection, nal-IRI), in combination with 5-fluorouracil and leucovorin, for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
