US FDA grants breakthrough therapy status to AbbVie’s venetoclax in combo with obinutuzumab for untreated adults patients with CLL

AbbVie announced that the US Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in combination with obinutuzumab as a fixed duration investigational combination, for untreated adult patients with chronic lymphocytic leukemia (CLL).

According to the FDA, this designation is intended to expedite the review of therapies for serious or life-threatening conditions. The designation coincides with the completion of the supplemental New Drug Application (sNDA) submission to the FDA for approval in previously-untreated CLL patients.

The FDA will review the venetoclax and obinutuzumab combination under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective cancer medicines are available to patients as early as possible.

The sNDA for the venetoclax and obinutuzumab combination is based on data from the phase 3 CLL14 trial, which studied patients receiving the combination treatment for 12 months as their first treatment for CLL. CLL14 is the first randomized trial in CLL to examine a chemotherapy-free, fixed duration treatment regimen.

VENCLEXTA is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis. The efficacy and safety of venetoclax in patients with previously-untreated CLL has not been evaluated by the US Food and Drug Administration, the European Medicines Agency or any health authority.