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FDA approves Onivyde as part of combination regimen for treatment of metastatic pancreatic cancer
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The FDA has approved the irinotecan liposome injection in combination with fluorouracil and leucovorin in the treatment of metastatic pancreatic cancer in patients previously treated with gemcitabine-based chemotherapy.
The irinotecan liposome injection (Onivyde; Merrimack) is a liposomal formulation of the topoisomerase I inhibitor irinotecan.
Richard Pazdur
The FDA had previously granted the agent Priority Review and orphan drug designations since it became apparent through trials that it would significantly improve the treatment of pancreatic cancer.
“Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA’s center for drug evaluation and research said in a press release. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”
It’s needed for pancreatic cancer, which is one of the most difficult cancers to diagnose early and has limited treatment options, especially once the disease metastasizes and surgery is no longer an option.
According to the NCI, there will be 48,960 new cases of pancreatic cancer diagnosed and 40,560 pancreatic cancer-related deaths in 2015.
The FDA approval came on the heels of study findings from a multi-arm, randomized, open label trial of 417 patients with metastatic pancreatic adenocarcinoma whose cancer grew following treatment with gemcitabine-based chemotherapy.
The design of the study was to compare Onivyde alone to Onivyde plus fluouracil and leucovorin and to fluouracil and leucovorin alone.
The data indicated that those patients receiving the combination treatment had a median OS of 6.1 months compared to 4.2 months for those treated with fluouracil and leucovorin alone. There was no improvement for Onivyde alone compared to fluouracil and leucovorin alone.
Additionally, those patients receiving the combination treatment had a median of 3.1 months PFS compared to 1.5 months PFS for fluouracil and leucovorin alone.
The safety profile for the drug was good in comparison as well, although the labeling for Onivyde does include a boxed warning about the potential risk for severe neutropenia and diarrhea.
Onivyde is also not approved for use as a single agent in this setting. –by Anthony SanFilippo