Celgene Plots Speedy FDA Filing for Agios Blood Cancer Drug
Summary
The application would be filed on an “accelerated” basis, meaning Celgene would head to the FDA seeking approval on a thinner body of evidence than usually required for a drug.According to the statement, the application would be based on data from Agios’s ongoing early-stage trial of enasidenib (formerly AG-221), which is being studied in patients with the blood cancer acute myeloid leukemia who have a specific genetic mutation.Some notable exceptions include Novartis’s imatinib (Gleevec), Pfizer’s crizotinib (Xalkori), and Millennium Pharmaceuticals’s bortezomib (Velcade).Celgene holds worldwide rights to enasidenib, and is paying all of its development costs; Agios would get milestone payments and royalties on the drug if it continues forward.If they make it to market, the drugs could represent a potential paradigm shift in the treatment of AML—a fast-moving blood cancer whose only cure is a bone marrow transplant that is only available to a small number of patients.
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