Sutent Cleared For Pancreatic Tumors, But With Caveat On Efficacy
This article was originally published in The Pink Sheet Daily
FDA approves Pfizer's sunitinib with labeling that states the magnitude of progression-free survival benefit seen in the pivotal study may have been overestimated due to the trial's early termination.
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Pfizer developed crizotinib and its companion diagnostic in just four years after identifying an aberrant ALK gene as the target, spanning a corporate restructuring, the Wyeth integration, and the departure of senior staff in the R&D organization and oncology BU. The next year or so will tell whether Xalkori was a flash in the pan, or whether it marks the long awaited turnaround for Pfizer’s oncology business and a model for nimble drug development.
Pfizer gained the therapy to treat a rare genetic neurologic disorder in its 2010 acquisition of folded protein company FoldRx.