OBR OncologyFDA Approves Irinotecan Liposome Combo in Metastatic Pancreatic Cancer

A Milestone in Metastatic Pancreatic Cancer Treatment: Unveiling the Efficacy of the Irinotecan Liposome Combination

In a significant advancement for the treatment of metastatic pancreatic adenocarcinoma, the US Food and Drug Administration (FDA) has approved the combination therapy of irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin as a first-line treatment option. This approval, based on the results of the NAPOLI 3 trial, marks a pivotal moment in the management of this aggressive cancer, offering hope for improved patient outcomes through a new treatment regimen that demonstrates a notable increase in overall survival compared to the standard initial treatment.

Key Points:

• On February 13, 2024, the FDA approved irinotecan liposome (Onivyde) in combination with oxaliplatin, fluorouracil, and leucovorin for first-line treatment of metastatic pancreatic adenocarcinoma.
• The approval was based on the NAPOLI 3 trial, a phase 3 study that showed significant improvement in overall survival (OS) and progression-free survival (PFS) with the new regimen compared to the standard treatment of nab-paclitaxel plus gemcitabine.
• NAPOLI 3 included 770 patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy for metastatic disease, demonstrating a median OS of 11.1 months with the new regimen versus 9.2 months with standard treatment.
• The treatment, NALIRIFOX, includes a specific dosing protocol for irinotecan liposome, oxaliplatin, fluorouracil, and leucovorin, emphasizing the importance of careful administration and monitoring due to potential severe adverse effects.
• Significant safety concerns associated with NALIRIFOX include severe and life-threatening neutropenia and diarrhea, necessitating strict adherence to guidelines for withholding treatment and managing side effects.
• The study highlights the first improvement in OS for first-line treatment of metastatic pancreatic cancer in over a decade, underscoring the long-standing need for more effective treatment options in this field.
• Ipsen, the manufacturer of Onivyde, noted that this is the second approval for an irinotecan liposome regimen in metastatic pancreatic adenocarcinoma, reinforcing the drug’s role in treating this challenging condition.

“We haven’t had a study show an [OS] improvement in pancreatic cancer in over a decade, since 2010 when nab-paclitaxel was approved. So, it’s been a long haul and despite many, many, many trials in that timeframe.”
– Zev A. Wainberg, MD, Lead Investigator, Professor of Medicine and Codirector of the University of California Los Angeles GI Oncology Program

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