Onivyde for Advanced Pancreatic Cancer Granted FDA Approval

The Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome; Merrimack Pharmaceuticals) injection in combination with fluorouracil and leucovorin for the treatment of metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

The FDA approval is based a three-arm, randomized, open-label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving the gemcitabine or a gemcitabine-based therapy. 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. Patients receiving Onivyde plus fluorouracil/leucovorin also had a delay in the amount of time to tumor growth compared to those who received fluorouracil/leucovorin; the average time for those receiving Onivyde plus fluorouracil/leucovorin was 3.1 months vs. 1.5 months for those receiving fluorouracil/leucovorin.

RELATED: FDA to Review NDA for Metastatic Pancreatic Adenocarcinoma Therapy

Onivyde includes a Boxed Warning on the risks of severe neutropenia and diarrhea. Previously, Onivyde was granted Orphan Drug designation and Priority Review status by the FDA.

For more information call (888) 463-6332 or visit FDA.gov.

Loading links....