The FDA has approved the use of Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The effectiveness of the drug was demonstrated in a 3-arm, randomized, open label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving gemcitabine treatment. According to the agency, results of the trial showed that patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only. In addition, patients receiving Onivyde plus fluorouracil/leucovorin had a delay in the amount of time to tumor growth compared to those who received fluorouracil/leucovorin. The average time for those receiving Onivyde plus fluorouracil/leucovorin was 3.1 months compared to 1.5 months for those receiving fluorouracil/leucovorin.
“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,” stated Dr.Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”
The National Cancer Institute predicts, there will be 48,960 new cases of pancreatic cancer diagnosed in the United States by the end of this year, and estimates that nearly 40,560 people will dies becauae of the disease. Part of the problem is that pancreatic cancer can be difficult to diagnose early and treatment options are limited, especially when the disease has spread to other parts of the body and surgery to remove the tumor is not possible. Notable victims of the disease include Steve Jobs, as well as actors Patrick Swayze and Richard Crenna.
The most common side effects of treatment with Onivyde included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth, and fever. Ovyde was also found to result in low counts of infection-fighting cells (lymphopenia and neutropenia). Death due to sepsis following neutropenia has been reported in patients treated with Onivyde.
Packaging for Onivyde includes a boxed warning to alert health care professionals about the risks of severe neutropenia and diarrhea. The drug is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.