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Onivyde Approval History

  • FDA approved: Yes (First approved October 22nd, 2015)
  • Brand name: Onivyde
  • Generic name: irinotecan liposomal
  • Dosage form: Injection
  • Previous name: MM-398
  • Company: Merrimack Pharmaceuticals, Inc.
  • Treatment for: Pancreatic Cancer

Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan indicated for the treatment of post-gemcitabine metastatic adenocarcinoma of the pancreas.

FDA Approval: The effectiveness of Onivyde was demonstrated in a study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed following gemcitabine-based therapy. Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin.

Mechanism: Onivyde is a novel encapsulation of irinotecan in a liposomal formulation. SN-38, the active metabolite of irinotecan, inhibits topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promotes cell death.

Administration: Onivyde is administered by intravenous infusion over 90 minutes every 2 weeks, prior to leucovorin and fluorouracil. Onivyde is not approved for use as a single agent.

Side Effects: Common side effects reported in clinical trials included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth (stomatitis) and fever (pyrexia). Onivyde was also found to cause lymphopenia and neutropenia.

Additional Information: The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of potentially life-threatening neutropenia and severe diarrhea. Onivyde may cause severe hypersensitivity reactions including anaphylactic reactions. Onivyde can cause fetal harm when administered to a pregnant woman, so females of reproductive potential should use effective contraception at all times during treatment, and for one month after the final dose. Males with female partners of reproductive potential should use effective contraception at all times during treatment, and for four months after the final dose. Nursing women should not breastfeed at any time during treatment, and for one month after the final dose.

Development History and FDA Approval Process for Onivyde

Oct 22, 2015Approval FDA Approves Onivyde (irinotecan liposome injection) for Advanced Pancreatic Cancer
Jun 25, 2015U.S. FDA Grants Priority Review for MM-398 New Drug Application
Apr 27, 2015Merrimack Pharmaceuticals and Baxter BioScience Announce Completion of NDA Submission for MM-398 as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer

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