FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde. The effectiveness of Onivyde was demonstrated in a phase III, three-arm, randomized, open label study of...
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