A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 08 Dec 2017
At a glance
- Drugs Duvelisib (Primary)
- Indications Chronic lymphocytic leukaemia; Follicular lymphoma; Marginal-zone-B-cell-lymphoma; Non-Hodgkin's lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms DYNAMO
- Sponsors Infinity Pharmaceuticals; Verastem
- 01 Nov 2017 According to a Verastem media release, company expects to submit the duvelisib NDA for the treatment of patients with relapsed or refractory CLL/SLL during the first quarter of 2018.
- 31 Oct 2017 According to a Verastem media release, based on the written feedback from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for duvelisib, the company intends to submit a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL).
- 06 Sep 2017 According to a Verastem Media Release, the company plans to share clinical data from DUO study with U.S. Food and Drug Administration (FDA) for filing a New Drug Application (NDA) with the FDA during the first half of 2018. The duvelisib NDA submission will be supported by favorable results from both DUO and DYNAMO studies.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History