The FDA approved irinotecan liposome injection (Onivyde, Merrimack Pharmaceuticals Inc.) in combination with fluorouracil (5-FU) and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
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According to the agency in a press release, Onivyde comes with a health warning to health professionals that taking it comes with the risk of severe neutropenia (low white blood cell count) and diarrhea. Onivyde is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.
The approval was based on a study of more than 400 patients.
The new formulation, which encapsulates conventional irinotecan in nanoparticle liposomes in an effort to improve the pharmacokinetics and tolerability, had been given priority review and orphan drug status in this setting. The study was created to determine whether patients receiving Onivyde plus fluorouracil/leucovorin or Onivyde alone lived longer than those receiving fluorouracil/leucovorin.
The most common side effects of treatment with Onivyde included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth (stomatitis) and fever (pyrexia). Pancreatic cancer accounts for about 3% of all cancer in the United States.
It is unknown what causes pancreatic cancers but ACS states that like most cancers, it can be caused DNA mutations.
Charles Fuchs, director of Dana Farber’s gastrointestinal cancer center, said, “This is affecting more and more Americans each year, and it is devoid of the kind of therapies we need to be effective”.
Approval was based on the findings of a 3-arm, open-label study that evaluated liposomal irinotecan plus 5-FU/leucovorin compared with liposomal irinotecan alone and 5-FU/leucovorin alone in 417 patients with metastatic pancreatic adenocarcinoma who had experienced disease progression following treatment with gemcitabine or gemcitabine-based therapy.
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Fuch said pancreatic cancer is so deadly because it is often discovered late – eliminating surgery as an option – and after tumors have formed walls of scar tissue.
