BioPharma Dive February 14, 2024
The clearance of Onivyde is backed by Phase 3 trial results showing a combination of it and chemo drugs modestly improved overall survival.
Dive Brief:
- The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be used with chemotherapy in treating recently diagnosed metastatic tumors, the company announced Tuesday.
- Onivyde, which Ipsen bought from Merrimack Pharmaceuticals seven years ago, has been available for second-line use in pancreatic cancer, after tumor progression. The new OK will give physicians the option to use it earlier.
- The FDA’s decision was based on results from a Phase 3 trial Ipsen ran involving 770 people with metastatic pancreatic cancer. The data showed that Onivyde plus the chemo...
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