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news.PharmaEngine has been submitted a new drug application (NDA) to the Taiwan Food and Drug Administration (TFDA) seeking approval for MM-398 (irinotecan liposome injection, also called nal-IRI) to treat patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
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MM-398 is a new, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan.
The filing follows the recent submissions of NDA and marketing authorization application (MAA) by its licensing partner, Merrimack Pharmaceuticals and its sublicensing partner, Baxter International’s BioScience business (BAX) to the US FDA and to the European Medicines Agency (EMA), respectively.
The NDA submission to the TFDA was based on positive data from a global, randomized, open label Phase III trial (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy.
PharmaEngine president and CEO Grace Yeh said: "This submission represents a significant milestone in the history of PharmaEngine. We are extremely grateful to our investigators, patients and their caregivers for their participation in making Taiwan the top recruitment region in this pivotal study. We are also thankful for the support from Merrimack in preparing our NDA.
"We look forward to working with our regulatory authority to offer a new treatment option to help the patients in fighting against their pancreatic cancer."
In NAPOLI-1, which was sponsored by Merrimack Pharmaceuticals, a total of 417 patients were randomized across the three arms.
Patients were given MM-398 (120mg/m2, every three weeks) as a monotherapy, MM-398 (80mg/m2, every two weeks) in combination with 5-FU/LV, and a shared control arm of 5-FU/LV.