FDA Approves Onivyde for Metastatic Pancreatic Cancer

Treatment used in combination with fluorouracil and leucovorin for patients with metastatic pancreatic cancer.

Treatment used in combination with fluorouracil and leucovorin for patients with metastatic pancreatic cancer.

The FDA last week announced the approval of Onivyde in combination with fluorouracil and leucovorin for the treatment of patients with metastatic pancreatic cancer who had previous treatment with gemcitabine-based chemotherapy.

According to the National Cancer Institute, there will be approximately 48,000 new cases of pancreatic cancer diagnosed in the United States in 2015 and nearly the same amount of deaths from the disease.

Pancreatic cancer is 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 an option.

A cohort of 398 patients were evaluated to observe the safety of Onivyde. Patients either received Onivyde alone, or in combination with fluorouracil/leucovorin.

Side effects from the treatment included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth, and fever. It was also found to result in low counts of infection-fighting cells.

Death due to sepsis following neutropenia has been reported in patients treated with Onivyde.

The label of Onivyde includes specific warnings about the risk of neutropenia and diarrhea with the utilization of the medication.

Onivyde is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.