The Food and Drug Administration approved irinotecan liposome injection, in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
The approval, granted after a priority review, was based on results from a three-arm, randomized, open-label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed after receiving a gemcitabine-based therapy. Median survival for patients treated with irinotecan liposome injection plus fluorouracil/leucovorin was 6.1 months, compared with 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only irinotecan liposome injection, compared with those who received fluorouracil/leucovorin, according to an Oct. 22 statement issued by the FDA.
The safety of irinotecan liposome injection was evaluated in 398 patients who received either the injection with fluorouracil/leucovorin, the injection alone, or fluorouracil/leucovorin. The most common side effects of irinotecan liposome injection included diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, pyrexia, lymphopenia, and neutropenia. The FDA warned that death due to sepsis following neutropenia has been reported in patients treated with irinotecan liposome injection, and labeling for the drug includes a boxed warning about the risks of severe neutropenia and diarrhea. The injection is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.
Irinotecan liposome injection, designated as an orphan drug, is being marketed as Onivyde by Merrimack Pharmaceuticals of Cambridge, Mass.
lnikolaides@frontlinemedcom.com
On Twitter @NikolaidesLaura