FDA approves new therapy for pancreatic cancer
pharmafile | October 30, 2015 | News story | Medical Communications, Sales and Marketing | FDA, Pancreatic cancer
The FDA has approved drug a pancreatic cancer drug, Onivyde, which has produced significant overall survival rates in an international clinical study.
Onivyde (irinotecan liposome injection) will be used as part of a combination regimen with two chemotherapy drugs, fluorouracil and leucovorin. It has been approved to treat patients with pancreatic cancer that has progressed after treatment with a different chemotherapy, gemcitabine-based therapy.
Symptoms of pancreatic cancer usually do not appear until the cancer is in its late stages, making it difficult to treat. Once the disease spreads to other parts of the body, most patients are not candidates for surgery and receive chemotherapy as their primary treatment.
The FDA granted priority review and orphan drug designations for Onivyde. Dr Richard Pazdur, director of the Office of Haematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research, says: “Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs. By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”
The approval is based on a Phase III study (NAPOLI-1 (NAnoliPOsomaL Irinotecan), sponsored by manhufacturer Merrimack Pharmaceuticals, of 417 participants who all had metastatic pancreatic cancer that was previously treated with the traditional standard-of-care, gemcitabine-based therapy.
Gayle Jameson, principal investigator, NAPOLI-1 study and associate investigator, HonorHealth Research Institute says: “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. 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.”
New treatment options are needed for pancreatic cancer. Only about one in four patients survive more than one year after diagnosis, and less than 10% survivor more than five years.
Yasmita Kumar
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