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News From the Food and Drug Administration
December 1, 2015

New Pancreatic Cancer Drug

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(21):2227. doi:10.1001/jama.2015.16166

Irinotecan liposome injection, marketed as Onivyde, has been approved in combination with fluorouracil and leucovorin to treat patients with metastatic pancreatic cancer who previously received gemcitabine-based chemotherapy.

In a study including 417 patients with metastatic pancreatic cancer that progressed after treatment with gemcitabine, those who took irinotecan with fluorouracil and leucovorin lived an average of 6.1 months compared with 4.2 months for those treated only with fluorouracil and leucovorin (

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