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ARTICLE | Product Development

Pivotal meeting

How Cornerstone’s CPI-613 leapfrogged to pivotal trials in AML, pancreatic cancer

Virginia Li, Staff Writer
March 25, 2017 2:51 AM UTC
The compound has Orphan Drug designation in AML, pancreatic cancer and myelodysplastic syndrome (MDS).

Cornerstone Pharmaceuticals Inc. was planning a traditional development pathway for CPI-613 in acute myelogenous leukemia and pancreatic cancer, but FDA nudged the company to go from Phase I to pivotal trials for both indications.

According to COO Sanjeev Luther it was FDA, not the company, that suggested an accelerated development timeline based on the strength of the Phase I data...

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