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FDA approves Merrimack's pancreatic cancer drug

Onivyde improves overall survival rates

The FDA has approved Merrimack's Onivyde for the treatment of advanced pancreatic cancer.

The approval comes on the back of clinical trial research that showed an increased survival rate of nearly two months without decreasing the quality of life compared to other treatments.

The study was conducted by researchers at HonorHealth Research Institute and the Translational Genomics Research Institute (TGen) and involved 417 patients who all had metastic pancreatic cancer that was previously treated with the gemcitabine-based standard of care.

Gayle Jameson, principal investigator at HonorHealth, said: “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.”

Nearly 50,000 people in the US are diagnosed with pancreatic cancer every year and more than 39,000 of these patients ultimately die, making it the fourth leading cause of cancer death.

Furthermore, only one in four patients survive more than a year after diagnosis and less than 10% survive more than five years.

Biopharmaceutical science company Baxalta has also payed $62.5m to Merrimack as Onviyde enters phase II trials as a first-line treatment for pancreatic cancer in combination with fluorouracil and leucovorin with or without the addition of oxaliplatin.

The global pancreatic cancer market is experiencing rapid expansion and is set to expand from $529m in 2012 to $1.6bn by 2017, largely driven by strong performance from Celgene's Abraxane (nab-paclitaxel).   

Article by
Nikhil Patel

29th October 2015

From: Regulatory



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