The U.S. Food and Drug Administration (FDA) approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been treated with gemcitabine-based chemotherapy on Thursday.
The FDA granted priority review and orphan drug designations for Onivyde. Priority review is granted to applications for drugs that would be a significant improvement in safety or effectiveness in the treatment of a serious condition.
Statistics from the National Cancer Institute indicate that 48,960 new cases of pancreatic cancer will be diagnosed in the United States by the end of 2015 - almost as many as the number of deaths caused by the disease, which is 40,560.
“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,” FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products Director Richard Pazdur said. “By using the priority review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival."
Onivyde 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.
