On April 27, 2015 Merrimack Pharmaceuticals and Baxter International reported that Merrimack has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection), also known as "nal-IRI," to the U.S. Food and Drug Administration (FDA) (Press release, Merrimack, APR 27, 2015, View Source [SID:1234503191]). Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The companies also announced that Merrimack has requested priority review of the MM-398 NDA by the FDA. Schedule your 30 min Free 1stOncology Demo! "The submission of Merrimack’s first ever NDA with the U.S. 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," said Robert Mulroy, President and CEO at Merrimack. "We are encouraged by the FDA’s support in the process and look forward to working with them throughout the NDA review."
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Merrimack’s application is based upon the results of an international Phase 3 study (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints by demonstrating 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. The most common Grade 3 or higher adverse events in patients receiving MM-398 and 5-FU/LV were neutropenia, fatigue and gastrointestinal effects. This was the first global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this aggressive disease. The data were previously presented in June 2014.
"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," said David Meek, head of Oncology at Baxter BioScience. "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."
The FDA and European Medicines Agency have granted MM-398 orphan drug designation for patients with metastatic pancreatic cancer. MM-398 was granted Fast Track designation by the FDA in November 2014.
Merrimack and Baxter International’s biopharmaceutical business (NYSE: BAX) entered into an exclusive licensing agreement to develop and commercialize MM-398 outside of the United States. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize MM-398 in Taiwan.
About MM-398
MM-398 (irinotecan liposome injection), also known as "nal-IRI," is a novel encapsulation of irinotecan in a long-circulating nanoliposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death.
About Pancreatic Cancer 1,2
Pancreatic cancer is rare and deadly, accounting for only three percent of all cancer cases worldwide but is the fourth leading cause of cancer death. An estimated 140,000 new cases are diagnosed every year around the world, two-thirds of which are among people aged 65 or older.
Because the signs and symptoms of pancreatic cancer are non-specific and may not appear until the disease has spread to other sites, approximately 80% of patients are diagnosed with late stage disease. These patients are not candidates for surgery, instead receiving chemotherapy as the mainstay of their therapy. This contributes to the five year survival rate for all patients being less than six percent; fewer than 20 percent of newly diagnosed patients survive more than two years. There is no consensus on the standard of care for patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.