The European Commission has approved Venclyxto in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia, who were previously untreated.
The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, Norway and the United Kingdom.
AbbVie sponsors the drug.
“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,” Neil Gallagher, chief medical officer and vice president of development at AbbVie, said in a statement.
This is the third approval for Venclyxto, a first-in-class B-cell lymphoma-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 III CLL14 clinical trial primary analysis (median follow up of 28 months), which demonstrated superior progression-free survival (PFS; the time on treatment without disease progression or death) 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 (hazard ratio 0.35; 95% CI (0.23,0.53), p<0.0001, medians not yet reached).
At an updated CLL14 efficacy analysis (median follow-up of 40 months), the median PFS had not been reached in the Venclyxto + obinutuzumab arm and was 35.6 months [95% CI: 33.7,40.7] in the obinutuzumab + chlorambucil arm (hazard ratio 0.31; 95% CI: 0.22, 0.44). The 36-month PFS estimate in the venetoclax plus obinutuzumab arm was 81.9% [95% CI: 76.5, 87.3] and in the obinutuzumab plus chlorambucil arm was 49.5% [95% CI: 42.4, 56.6]. Additionally, after completing one year of treatment, patients treated with the VENCLYXTO combination experienced deep response as measured by higher rates of undetectable minimal residual disease or complete response as compared to patients receiving a standard of care regimen.
