Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin can be used to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy, said the U.S. Food and Drug Administration in a press release on October 22, 2015.
"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. By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
The drug regulator granted Priority Review and orphan drug designations for Onivyde. A study demonstrated the effectiveness of Onivyde. The three-arm, randomized, open label study involved as many as 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy.
Investigators found 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 fluorouracil/leucovorin.
The safety of Onivyde was also tested in 398 patients who received either Onivyde with fluorouracil/leucovorin, Onivyde alone or fluorouracil/leucovorin. Merrimack Pharmaceuticals of Cambridge, Massachusetts holds the marketing authority of Onivyde.