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Incyte Pulls Parsaclisib Files As FDA Takes Foot Off Accelerator

Was Seeking Accelerated Approval For PI3K inhibitor For Lymphoma

 
• By Kevin Grogan

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.

red lights
FDA no longer keen on accelerated approval green lights • Source: Alamy

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.

The US biotech noted that it was withdrawing the new drug application for parsaclisib for the treatment of relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle...

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