Cancer drug Onivyde receives FDA approval

The Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, for patients with advanced pancreatic cancer who have been treated previously with gemcitabine-based chemotherapy.

The National Cancer Institute said 48,960 cases of pancreatic cancer will be diagnosed in the United States by the end of 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,” Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival."

The FDA has granted Priority Review and orphan drug designations for Onivyde. It was the subject a three-arm, randomized, open label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer worsened after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy.