EC approval for AbbVie’s VENCLYXTO® combination regimen

AbbVie gets EC approval for VENCLYXTO® combination regimen

AbbVie has announced that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who were previously untreated. VENCLYXTO is being developed by AbbVie and Roche.

The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, Norway and the United Kingdom.

This is the third approval for VENCLYXTO, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLYXTO is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

This most recent approval is based on results from the Phase 3 CLL14 clinical trial primary analysis (median follow up of 28 months), which demonstrated superior progression-free survival  as assessed by investigators in patients treated with VENCLYXTO plus obinutuzumab compared to patients who received a standard of care chemotherapy regimen of chlorambucil plus obinutuzumab.

Dr Neil Gallagher, Chief Medical Officer and Vice President of Development, said: “This approval underscores the growing utility of VENCLYXTO in treating CLL and demonstrates its clinical benefit as a chemotherapy-free combination therapy option for CLL patients in Europe who have not yet been treated.”