Novel therapy gets FDA approval for patients with metastatic pancreatic adenocarcinoma

Today, The U.S. Food and Drug Administration (FDA) approved a novel therapy for patients with metastatic pancreatic adenocarcinoma – the most common form of pancreatic cancer – whose disease has progressed following gemcitabine-based therapy, offering new hope against a disease that will claim the lives of more than 40,000 individuals this year.

"This is a pivotal achievement for the pancreatic cancer community because it provides a new treatment option for some patients facing this difficult disease," said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. "We applaud the dedication of those involved in this advancement, knowing it will impact our goal to double pancreatic cancer survival by 2020."

ONIVYDE™ (irinotecan liposome injection), in combination with fluorouracil (5-FU) and leucovorin, is the first-ever therapy approved by the FDA for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy.

The FDA's approval of ONIVYDE in combination with 5-FU and leucovorin is based on results from an international phase III clinical study, further illustrating clinical trials as the mechanism that enables improvements in patient outcomes.

According to Merrimack Pharmaceuticals, the maker of ONIVYDE, the therapy was found to improve median overall survival from 4.2 to 6.1 months when compared to the control group of patients who received 5-FU and leucovorin alone.

At present, the five-year survival rate is a mere seven percent. To combat these statistics, the Pancreatic Cancer Action Network set a bold and aggressive goal to double pancreatic cancer survival by 2020.

"This ambitious goal is only possible with positive results from clinical trials and the approval of new therapies like this one. We encourage all patients with pancreatic cancer to consider clinical trials when looking at their treatment options," added Fleshman.