The United States Food and Drug Administration (FDA) approved Onivyde (irinotecan liposome injection) to be used in combination with fluorouracil and leucovorin for patients with advanced pancreatic cancer.
The approval is indicated for patients with pancreatic cancer that has spread to distant sites in the body who have received prior treatment with the chemotherapy agent, Gemzar® (gemcitabine). The combination of Onivyde/fluorouracil/leucovorin is often referred to as MM-398.
The pancreas is an organ in the abdomen that resides behind the lower part of the stomach. The pancreas helps aid digestion by releasing certain enzymes. In addition, the pancreas releases hormones, such as insulin, that helps to regulate sugar metabolism.
Pancreatic cancer often has no symptoms until it has spread from its site of origin. Once the cancer has spread, particularly if surgical removal is no longer an option, effective treatment options remain limited.
This approval was based on a clinical trial that that included 417 patients with advanced pancreatic cancer who had received prior therapy with Gemzar. Patients were divided into three treatment groups: one group was treated with Onivyde plus fluorouracil/leucovorin; one group was treated with Onivyde only; and one group was treated with fluorouracil/leucovorin only.
- Survival was 6.1 months for patients treated with Onivyde/fluorouracil/leucovorin, compared to 4.2 months for patients treated with fluorouracil/leucovorin.
- There was no survival improvement among patients treated with Onivyde only compared to patients treated with fluorouracil/leucovorin.
- Time to cancer growth was 3.1 months for patients treated with Onivyde/fluorouracil/leucovorin, compared with only 1.5 months for those treated with fluorouracil/leucovorin.
The most commonly reported side effects of treatment with Onivyde were diarrhea, fatigue, vomiting and nausea.
Reference: United States Food and Drug Administration. FDA approves new treatment for advanced pancreatic cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468654.htm. Accessed October 23, 2015.
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