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news.Merrimack Pharmaceuticals has completed the rolling submission of the new drug application (NDA) to the US Food and Drug Administration (FDA) for MM-398 (irinotecan liposome injection), also called 'nal-IRI', to treat post-gemcitabine metastatic pancreatic cancer.
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The company is seeking US marketing approval of MM-398 to treat patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
Earlier, Merrimack and Baxter International’s biopharmaceutical business entered into an exclusive licensing agreement to develop and commercialize MM-398 outside of the US, while PharmaEngine holds the rights to commercialize the drug candidate in Taiwan.
The companies have also noted that Merrimack has requested priority review of the MM-398 NDA by the FDA.
Merrimack president and CEO Robert Mulroy said: "The submission of Merrimack’s first ever NDA with the US FDA is a major milestone in the company’s history and a significant step forward in our commitment to delivering new treatment options to cancer patients.
"We are encouraged by the FDA’s support in the process and look forward to working with them throughout the NDA review."
The NDA is based upon the results of an international Phase III trial (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy.
The company said that MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints by showing a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and leucovorin.
Baxter BioScience Oncology head David Meek said: "This is an important achievement in our MM-398 collaboration and in our collective efforts to introduce a potentially valuable new standard of care treatment for patients with pancreatic cancer.
"We intend to maintain this positive momentum as we prepare for the European submission in the coming months, with additional global submissions to follow shortly thereafter."
Both FDA and the European Medicines Agency (EMA) have granted orphan drug designation for MM-398 to treat patients with metastatic pancreatic cancer, while the drug candidate also secured FDA fast track designation in November 2014.