Onivyde Approved for Advanced Pancreatic Cancer

Patients with metastatic pancreatic cancer who have progressed on gemcitabine now have the option of Onivyde combined with leucovorin/fluorouracil.

Pancreatic cancer patients who have progressed on the standard of care gemcitabine now have another option. The FDA today approved Onivyde (irinotecan liposome) in combination with fluorouracil and leucovorin for this patient population.

Pancreatic cancer sees a very high mortality rate because the disease is diagnosed late, when the patient is at an advanced stage, due to alck of symptoms.

Onivyde was granted both Priority Review and orphan drug designation by the regulatory authority. In a 3-arm, randomized, open-label study with 417 patients with metastatic pancreatic adenocarcinoma, who had relapsed on a gemcitabine-based regimen. The study evaluated whether Onivyde plus leucovorin/fluorouracil or Onivyde alone improved survival than when patients were treated with leucovorin/fluorouracil alone. Including Onivyde in the regimen improved patient survival by about 2 months, the trial showed.

Read the FDA press release here.