Now that the enthusiasm of US regulators for cancer drug accelerated approvals has been well and truly curbed,Incyte Corporation has taken a "business decision" to pull its submissions for parsaclisib for non-Hodgkin’s lymphomas, for which a verdict was expected soon.
Incyte Pulls Parsaclisib Files As FDA Takes Foot Off Accelerator
Was Seeking Accelerated Approval For PI3K inhibitor For Lymphoma
After discussions with the FDA, which has made its feelings clear on accelerated approvals, Incyte has concluded it cannot complete the confirmatory trials in lymphomas that would be needed on parsaclisib in time to make them worth their while.
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