FDA Grants Breakthrough Therapy Designation to Venetoclax for Patients with Relapsed/Refractory CLL with 17p Deletion

Earlier today the FDA granted the Breakthrough Therapy Designation to venetoclax (ABT-199). Venetoclax was awarded this designation for the treatment of relapsed or refractory CLL in previously treated patients with 17p deletion. Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein.

The Breakthrough Therapy Designation is intended to expedite the development and review of drugs for life-threatening conditions, based on preliminary clinical evidence. A full list of targeted treatments that have received FDA approval for the treatment of lymphoma can be found here.

Currently the Lymphoma Program has several phase 2 trials open to accrual for ABT-199 as a treatment for CLL patients. Dr. Richard Furman is the principal investigator for both trials:

Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects with Relapse or Refractory to B-cell Receptor Signaling Pathway Inhibitor Therapy

Phase 2 Open-Label Study of the Efficacy of ABT-199 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

A full listing of available CLL trials can be found here. Look to this space for more information regarding developments for the treatment of CLL.

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