· FDA has approved a new drug called Onivyde as part of a treatment regimen for advanced pancreatic cancer.
· Onivyde (irinotecan liposome injection) was approved to be used in combination with fluorouracil and leucovorin.
· The combination was approved for use in patients with advanced pancreatic cancer who were already treated with gemcitabine-based chemotherapy
· Approval was based on a study of more than 400 patients.
· All had experienced cancer growth despite gemcitabine-based chemotherapy.
· The new research included three treatment arms. Patients were randomly assigned to receive:
o Onivyde with fluorouracil/leucovorin
o Onivyde alone
o fluorouracil/leucovorin alone
· Researchers found that people treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin
· No survival benefit for patients who received Onivyde alone compared to those who received only fluorouracil/leucovorin
· Study also found that the average amount of time to tumor growth was 3.1 months for patients who received Onivyde plus fluorouracil/leucovorin compared to 1.5 months for those who received only fluorouracil/leucovorin.
· Most common side effects of Onivyde were diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth and fever
· Drug also led to low counts of infection-fighting cells (lymphopenia and neutropenia).
· Death due to sepsis following neutropenia has been reported in patients taking Onivyde.
· U.S. National Cancer Institute - Nearly 49,000 new cases of pancreatic cancer will be diagnosed in the United States this year and there will be more than 40,500 deaths from the disease
· Pancreatic cancer is difficult to diagnose early and there are limited treatment options, especially when it has spread to other parts of the body and surgery to remove the tumor is not possible.