A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

Trial Profile

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
  • Most Recent Events

    • 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.
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