FDA Grants Priority Review to Duvelisib for CLL/SLL and Follicular Lymphoma
The FDA is reviewing a New Drug Application, which is requesting full approval for CLL/SLL and accelerated approval for follicular lymphoma.
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.
- 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.