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FDA Grants Priority Review to MM-398 for Metastatic Pancreatic Cancer
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The FDA today granted priority review to MM-398 — an irinotecan liposome injection also known as “nal-IRI” — for the treatment of patients with metastatic pancreatic cancer who were previously treated with gemcitabine, according to a press release from the drug’s manufacturer.
The FDA based its decision on results of NAPOLI-1, a phase 3 international study that evaluated MM-398 (Merrimack Pharmaceuticals and Baxalta) in patients with metastatic pancreatic cancer who were previously treated with a gemcitabine-based therapy. The addition of MM-398 to 5-FU and leucovorin statistically significantly improved OS, PFS and overall response rate, — the study’s primary and secondary endpoints — according to the press release.
The most common grade 3 or worse adverse events that occurred in patients who received the combination of MM-398, 5-FU and leucovorin were neutropenia, fatigue and gastrointestinal effects.
NAPOLI-1 was the first global 3 study to show a survival benefit in this setting.
Researchers presented data from NAPOLI-1 earlier this month at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer and at the Gastrointestinal Cancers Symposium in January.
"The rapid timeline associated with priority review designation brings Merrimack closer to our goal of making MM-398 available to patients with pancreatic cancer who have been previously treated with gemcitabine and are in significant need of treatment options," Robert J. Mulroy, president and CEO of Merrimack Pharmaceuticals, said in a press release. "We look forward to working with the FDA as they review the application over the next several months."