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The Food and Drug Administration has granted Priority Review designation to MM-398 (irinotecan liposome injection, "nal-IRI") for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

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MM-398, marketed by Merrimack Pharmaceuticals and Baxalta Incorporated, is a novel encapsulation of irinotecan in a long-circulating liposomal formulation. The activated form of irinotecan is SN-38, which inhibits topoisomerase I.


The FDA had previously granted the drug both Orphan Drug and Fast Track designation for this indication.


The Priority Review designation shortens the time to complete a drug's review and aims to deliver a decision on approval for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act. The FDA action date for MM-398 for this indication is October 24.


MM-398 has been evaluated in the international Phase III study NAPOLI-1, which included 417 patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. The data were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer last year (OT 9/25/14 issue). The primary endpoint of overall survival was met for the MM-398-5FU/leucovorin combination. Median survival times were 6.1 months for the patients receiving the MM-398 combination, 4.9 months for the patients receiving MM-398 alone, and 4.2 months for the patients in the control group receiving fluorouracil/leucovorin.


The most common grade 3 or higher adverse events in patients receiving MM-398 and fluorouracil/leucovorin were neutropenia, fatigue, and gastrointestinal effects.