FDA approves new drug for advanced pancreatic cancer

CANCER DIGEST – Oct. 26, 2015 –  Patients with advanced pancreatic cancer now have a new FDA approved drug, Onivyde, that increased overall survival rates by two months in an international clinical study conducted in part by researchers at HonorHealth Research Institute and the Translational Genomics Research Institute (TGen).

The effectiveness of Onivyde was demonstrated in a three regimen comparison study of 417 patients with metastatic pancreatic cancer that had grown after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy. 

Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only Onivyde compared to those who received fluorouracil/leucovorin.

"Results from our clinical trial research showed a patient survival rate of nearly two more months without decreasing the quality of life compared to the other treatments tested, " said Gayle Jameson, principal investigator, NAPOLI-1 study and associate investigator, HonorHealth Research Institute. "Invariably pancreatic cancer progresses at some point and we don't have a universal standard of what to do next.  In this disease, two months of survival is a game changer for treating advanced pancreatic cancer and gives patients hope."

The large, randomized clinical trial that evaluated the new drug, the NAPOLI-1 (NAnoliPOsomaL Irinotecan), was sponsored by Merrimack Pharmaceuticals. It evaluated patients enrolled at more than 100 sites in North America, South America, Europe, Asia and Australia, including patients at HonorHealth Research Institute.