Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
The US Food and Drug Administration (FDA) granted Priority Review to duvelisib for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or follicular lymphoma, according to a press release.1 The drug’s manufacturer is seeking full approval for relapsed/refractory CLL/SLL and accelerated approval for relapsed/refractory follicular lymphoma.
Duvelisib, a first-in-class dual inhibitor of PI3K-delta and -gamma, was evaluated in patients with relapsed/refractory CLL/SLL in the randomized phase 3 DUO trial (ClinicalTrials.gov Identifier: NCT02004522) and in patients with refractory indolent non-Hodgkin lymphoma in the single-arm phase 2 DYNAMO trial (ClinicalTrials.gov Identifier: NCT01882803). The primary endpoints of both studies were met.
The FDA is reviewing a New Drug Application, which is requesting full approval for CLL/SLL and accelerated approval for follicular lymphoma. The target action date is October 5, 2018.
Duvelisib previously received Fast Track Designation for patients with CLL who progressed after at least 1 therapy and for patients with follicular lymphoma who progressed after at least 2 therapies. The drug is also being developed for patients with peripheral T-cell lymphoma.
Reference
FDA accepts New Drug Application for duvelisib and grants Priority Review [news release]. Boston, MA: BusinessWire; April 9, 2018. https://www.businesswire.com/news/home/20180409005377/en/. Accessed April 9, 2018.
This article originally appeared on Cancer Therapy Advisor
