Kentucky’s Pikeville Medical Center is seeing positive results from a number of cancer-based clinical trials, including an investigational drug for pancreatic cancer. After successful results observed at Pikeville Medical Center, the FDA has given the drug fast-track status. Although not disclosed in the source article, TrialSite News found that the Kentucky-based research site has been working on Ipsen’s Liposomal Irinotecan (ONIVYDE®) as part of a combination therapy for metastatic pancreatic cancer.
Pancreatic cancer is a rare and deadly disease that accounts for about 3% of all cancer and 7% of all cancer deaths. Of the 57,600 people with pancreatic cancer in America, over half are diagnosed with metastatic disease, which has an overall 5-year survival rate of the 3%.
Pikeville Medical Center PI Comments
Dr. Chris Croot noted recently, “These are trials for FDA approval and, in fact, one of the trials we have for advanced pancreatic (cancer), that trial just received fast track from the FDA. So the FDA says this is the hottest thing right now for pancreatic cancer.”
Although the name of the drug wasn’t mentioned in the news article, TrialSite News found a study that Pikeville Medical Center is participating in as a site. Launched back in February to investigate the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel and gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
The study sponsor, Ipsen, received FDA fast track designation for Liposomal Irinotecan (ONIVYDE®) as a first-line combination treatment for metastatic pancreatic cancer here.
ONIVYDE® is approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
Ipsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 149 countries, is responsible for the commercialization of ONIVYDE® outside of the United States and Taiwan. PharmaEngine owns commercial rights to ONIVYDE® in Taiwan.
A French biopharmaceutical company, Ipsen is headquartered in Paris. They develop and market medications used in oncology, neuroscience, and rare diseases along with consumer healthcare products. With over 5,800 employees, they have become truly a global company.
Call to Action: The FDA fast-track makes this an interesting potentially unfolding situation for those struggling with metastatic pancreatic cancer. TrialSite News monitors these studies. Sing up for the daily newsletter for daily updates.