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FDA Approves Onivyde for Pancreatic Cancer

Medication to be used following disease progression on gemcitabine-based therapy

Irinotecan liposome injection (Onivyde, Merrimack) has received FDA approval in combination with flurouracil (5-FU) and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. It is the only medication approved with this indication.

According to Merrimack, the FDA approval is based on the results of an international, phase III, randomized controlled study (NAPOLI-1).  In this study, irinotecan liposome injection in combination with 5-FU and leucovorin achieved its primary endpoint of a significant improvement in overall survival (OS) (P = 0.014, unstratified hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.50–0.93). There was a 45% improvement in median OS of 6.1 months for patients receiving the irinotecan liposome injection combination regimen, compared with 4.2 months for patients who received 5-FU and leucovorin alone.  The irinotecan liposome injection combination also demonstrated improvement in progression-free survival (3.1 months versus 1.5 months; HR, 0.55; 95% CI, 0.41–0.75).

The monotherapy regimen in this study did not achieve its primary endpoint; therefore, irinotecan liposome injection is not indicated as a single agent.

The most common adverse reactions (20% or more) associated with the medication were diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, and pyrexia, while the most common severe laboratory abnormalities (at least 10% Grade 3 or 4) were lymphopenia and neutropenia. 

Approximately 49,000 patients are diagnosed with pancreatic cancer each year in the United States, the overwhelming majority of whom have adenocarcinoma. Most patients receive gemcitabine-based therapy during either adjuvant/neoadjuvant treatment for locally advanced disease or during first- or second-line therapy for metastatic disease, but these patients are left with no standard-of-care therapy upon progression.

Source: Merrimack, October 22, 2015.

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