The US Food and Drug Administration (FDA) has approved the combination of irinotecan liposome injection (Onivyde) plus 5-fluorouracil and leucovorin for the treatment of patients with metastatic pancreatic cancer whose disease has progressed on gemcitabine-based chemotherapy. The drug is a nanotherapeutic that consists of irinotecan molecules encapsulated in a 100 mm liposome sphere.
The combination is the only FDA-approved therapy option available for progressive metastatic pancreatic cancer.
The FDA approval is based on the results of the open-label, phase III NAPOLI-1 trial. The combination of irinotecan liposome injection plus 5-fluorouracil and leucovorin resulted in a 1.9-month survival improvement compared with 5-fluorouracil and leucovorin alone (6.1 months vs 4.2 months; P = .014).
"This is an important day for patients facing pancreatic cancer," said Andrea Wang-Gillam, MD, PhD, associate professor of medicine and clinical director of the GI Oncology Program at the Washington University School of Medicine, St. Louis, Missouri, in a press release. Dr. Wang-Gillaman was one of the investigators of the NAPOLI-1 study.
The irinotecan liposome injection arm of the study also demonstrated a progression-free survival advantage over the control arm (3.1 months vs 1.5 months).
There will be about 48,960 new cases of pancreatic cancer diagnosed in the United States in 2015, according to the National Cancer Institute, and about 40,560 deaths from the disease. Pancreatic cancer is often diagnosed at a later, advanced stage when it is difficult to treat and removal of the tumor is not possible.
The drug carries a black box warning about the risk of severe neutropenia and diarrhea.
The most common side effects, experienced in more than 20% of patients, were diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common grade 3/4 laboratory abnormalities, occurring in more than 10% of patients, were lymphopenia and neutropenia. Death from sepsis was also reported in patients treated with Irinotecan liposome injection.