- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Merrimack Pharmaceuticals (NASDAQ:MACK) and commercialization partner Shire plc's (NASDAQ:SHPG) ONIVYDE (irinotecan liposome injection), in combination with the chemo agents fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic adenocarcinoma who have progressed after gemcitabine-based therapy.
- The positive opinion was based on the Phase 3 NAPOLI-1 study that showed pancreatic cancer patients treated with ONIVYDE plus 5-FU and leucovorin achieved overall survival of 6.1 months compared to 4.2 months for those receiving 5-FU and leucovorin alone (p=0.012) with a 33% reduction in the risk of death (hazard ratio: 0.67). One in four patients treated with the ONIVYDE regimen survived at least one year.
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ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
- Shire has global development and commercialization rights to ONIVYDE except the U.S. and Taiwan.
- The FDA approved ONIVYDE for this indication in October 2015.
- A final decision from the European Commission usually takes ~60 days.