Effective January 1, 2017 - New permanent J-code for ONIVYDE: J9205, injection, irinotecan liposome, 1 mg This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice.

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NCCN Recommendation as a Category 1 Treatment

Liposomal irinotecan (ONIVYDE) + 5-FU/LV is a Category 1 option in the post-gemcitabine metastatic pancreatic cancer setting1

Tumor type Line of therapy NCCN
recommendation
NCCN category
Tumor type Metastatic
pancreatic cancer
Line of therapy Second-line, with
previous gemcitabine-
based therapy
NCCN
recommendation
5-FU + leucovorin +
liposomal irinotecan
for patients with
metastatic pancreatic
cancer who have a
good performance
status*
NCCN category 1

ECOG=Eastern Cooperative Oncology Group; PS=performance status.

*ECOG 0-1 with good pain management, patent biliary status, and adequate nutritional intake.

Therapies are categorized on the following rating system based on National Comprehensive Cancer Network® (NCCN®) categories of evidence and consensus. 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate; 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate; 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate; 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate. All recommendations are category 2A unless otherwise noted.

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**National Comprehensive Cancer Network® (NCCN®).

Reference: 1. NCCN Guidelines Version 1.2016, 03/22/16 © National Comprehensive Cancer Network, Inc. 2016. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma V.1.2016. © National Comprehensive Cancer Network, Inc.; 2016. All rights reserved. Accessed [April 15, 2016]. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

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INDICATION AND IMPORTANT
SAFETY INFORMATION