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U.S. FDA Approves New Treatment for Patients with Metastatic Pancreatic Cancer
ONIVYDE™ is the first and only therapy approved by the FDA for the treatment of patients with metastatic adenocarcinoma who have been previously treated with gemcitabine-based therapy
Dear friend,
I am pleased to share some very good news that you may have read in yesterday's headlines.
ONIVYDE™ (irinotecan liposome injection) was approved by the U.S. Food and Drug Administration, in combination with fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic adenocarcinoma (the most common type of pancreatic cancer) whose disease progressed following treatment with gemcitabine-based therapy.
With this approval, ONIVYDE becomes the first and only FDA-approved treatment option for this patient population.
Last spring, I shared encouraging news of the clinical trial results from Merrimack Pharmaceuticals, Inc., NAPOLI-1 phase III clinical trial. This approval is the rewarding culmination of the lengthy process of scientific discovery that involved designing and running a clinical trial in order to demonstrate the effectiveness of a new treatment option for pancreatic cancer patients.
More hope is now here. The nearly two-month overall survival increase (6.1 months vs. 4.2 months) will translate, for many, to more days with their family and friends. This news also speaks to the critical need for designing clinical trials that go beyond first-line therapy to provide options for patients at every stage of disease. The approval of this treatment option is also a call to action for all pancreatic cancer patients to consider clinical trials as a treatment option. There can only be new treatment options if patients enroll in clinical trials, and we are extremely grateful to all of the patients who participated in this study. It is also important to realize that although two months may seem modest, this is an average overall survival improvement.
We are grateful to Merrimack Pharmaceuticals for its dedication to making a difference in the treatment of this deadly cancer. We are also grateful to all of you who recognize that by standing together and showing support for this cause in many ways, we can make progress to achieve our goal of doubling survival by 2020.
Wage Hope with us,
Julie Fleshman, JD, MBA
President and CEO
P.S. At the Pancreatic Cancer Action Network, we provide personalized clinical trials searches and guidance to patients and caregivers. For those who contact our Patient Central Associates for trial searches, 15% choose to enroll as compared to just 4.5% as a national average. We need even more patients participating in trials to expedite progress, and with your support we can have more hopeful treatment announcements in the months and years to come. You can search available trials using our Clinical Trial Finder, accessible through our website, www.pancan.org or contact a Patient Central Associate at patientcentral@pancan.org or 877-272-6226 from 7 a.m. – 5 p.m. Pacific Time.
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