FDA APPROVES “ONIVYDE” THERAPY FOR METASTATIC PANCREATIC CANCER
October 26, 2015
International Clinical Trial Led By TGen and Honor Health Showed Significant Overall Survival Rates
NEW LIFE EXTENDING HOPE. Patients with advanced metastatic adenocarcinoma pancreatic cancer now have access to the new FDA approved drug therapy, Onivyde. The International clinical study that led to approval by the FDA was conducted in part by Translational Genomics Research Institute (TGen) and Honor Health Research Institute.
About 75% of patients will not survive one-year. Many will not survive for a few months or even a few weeks.
“Results from our clinical trial research showed a patient survival rate increase of nearly two more months (6.1 month versus 4.2 months) without decreasing quality of life to other treatments tested,” said Gayle Jameson, principle investigator, NAPOLI-1 study and associative investigator, Honor Health Research Institute. “Invariably pancreatic cancer progresses at some point of time and we don’t have a universal standard of what to do next. In this disease, two months increase in survival is a game-changer and gives patients new hope.”
“As part of the team of medical researchers who studied the effectiveness of MM-398 plus 5-FU and leucovorin drug combination, we are thrilled that the FDA has approved the drug for use in patients throughout the nation,” said Dr. Daniel D. Von Hoff, MD, FACP, global principal investigator of the NAPOLI-1 study, Chief Scientific Officer for HonorHealth Research Institute and Physician-In-Chief and Distinguished Professor at TGen.
ONIVYDE therapy is now approved for pancreatic patients with advanced metastatic adenocarcinoma who have progressed on Gemcitabine alone or in a Gemcitabine-based treatment even including Gemcitabine + Abraxane. The large randomized International clinical trial that evaluated the new drug, the NAPOLI-1 (NAnoliPOsomal – innoctecan) was sponsored by Merrimack Pharmaceuticals.
It evaluated patents enrolled at more than 100 sites in North America, South America, Europe, Asia and Australia, including patients at Honor Health Research Institute in the Phoenix, Scottsdale area. The total of 417 patients in the clinical study all had metastatic advanced adenocarcinoma that fit the Gemcitabine-based therapy with the progressive improvement requirement.
This represents a new call for patients to consider participating in clinical trials that will eventually lead to greater treatment options, more significant life extension, and ultimately a cure of this brutal disease.