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FDA Approves MM-398 Regimen for Metastatic Pancreatic Cancer

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has approved MM-398 (irinotecan liposome injection; Onivyde) in combination with 5-fluorouracil (5-FU) and leucovorin as a treatment for patients with metastatic pancreatic cancer following prior administration of a gemcitabine-based regimen.

The approval was based on data from the phase III NAPOLI-1 trial, which demonstrated a 1.9-month improvement in overall survival (OS) with the addition of MM-398 to 5-FU and leucovorin. In the combination arm, the median OS was 6.1 months compared with 4.2 months with 5-FU and leucovorin alone (HR, 0.57; 95% CI, 0.41-0.80; P = .0009).

"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, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. "By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival." Click here to read the full article at OncLive.com

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