The U.S. Food and Drug Administration has approved Onivyde in combination with fluorouracil and leucovorin to treat patients with advanced pancreatic cancer.
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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.
Source-Medindia