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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MEI/Kyowa Kirin will no longer seek accelerated approval based on a single-arm study as the FDA is calling for Phase III data due to growing conservatism regarding the PI3K class.
Incyte’s next-generation PI3K-delta inhibitor, parsaclisib, and Nobelpharma’s topical sirolimus gel are among the latest marketing authorization applications that have been filed in the EU.
The company plans to conduct additional analyses of data from ongoing trials that are testing its PI3K inhibitor in combination with rituximab for treating types of indolent B-cell non-Hodgkin’s lymphoma.