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The U.S. Food and Drug Administration has approved Onivyde (irinotecan liposome injection) for use in combination with fluorouracil and leucovorin to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

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Onivyde-also known as MM-398 and marketed by Merrimack Pharmaceuticals Inc.-is a novel encapsulation of irinotecan in a liposomal formulation that works by inhibiting topoisomerase I-an essential enzyme involved in DNA transcription and replication-and promoting cell death.


"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 FDA's Office of Hematology and Oncology Products, said in a news release. According to estimates from the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. this year and 40,560 deaths.


"By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival," Pazdur said.


Onivyde is approved after having received priority review and orphan drug designations from the FDA (OT 7/25/15 issue).


Effectiveness Data

Effectiveness for Onivyde was demonstrated in the three-arm, randomized, open-label NAPOLI-1 study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving gemcitabine or a gemcitabine-based therapy. The patients in the study who received Onivyde plus fluorouracil(5-FU)/leucovorin lived 6.1 months on average, compared with 4.2 months for patients who received 5-FU/leucovorin.


Because the primary endpoints were not reached in the study for patients who received Onivyde as monotherapy, the drug is not approved as a single agent, the FDA noted. Patients receiving Onivyde plus 5-FU/leucovorin had an average delay in the amount of time to tumor growth of 3.1 months compared with 1.5 months for those who received 5-FU/leucovorin.


Safety and Boxed Warning

Safety was evaluated in 398 of the patients on the trial. The most common side effects of treatment with Onivyde were diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common serious adverse reactions with Onivyde were lymphopenia and neutropenia.


The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of severe neutropenia and diarrhea.


Clinical Quick Facts: Onivyde

Drug: Onivyde (irinotecan liposome injection)


Approved Indication: Treatment of patients with metastatic pancreatic cancer-in combination with fluorouracil and leucovorin-who have been previously treated with gemcitabine-based chemotherapy


Serious Side Effects: Lymphopenia and neutropenia


Common Side Effects: Diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, and pyrexia