Incyte Reports the US FDA’s Acceptance of NDA for Parsaclisib to Treat R/R Non-Hodgkin Lymphomas

November 1, 2021 Auto Bot FDA, Incyte, NDA, regulatory 0

Shots:

  • The submission is based on P-II studies i.e., CITADEL-203/204/205 that evaluate parsaclisib in patients with r/r FL, MZL & MCL. The anticipated PDUFA date for parsaclisib in adult patients with r/r FL is Aug 30, 2022.
  • The results from the studies showed that Parsaclisib was generally well-tolerated with a manageable safety profile
  • The FDA grants the priority review of parsaclisib for r/r MZL who have received at least one prior anti-CD20-based regimen & for MCL who have received at least one prior therapy & the designation shortens the review period by 4mos. as compared to standard review. The anticipated PDUFA date is April 30, 2022

Click here to­ read the full press release/ article | Ref: Incyte | Image: Incyte

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