Venetoclax + obinutuzumab combo to treat CLL in EUApril 4, 2020
AbbVie announced that the European Commission (EC) has approved venetoclax (Venclyxto) in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who were previously untreated.
This is the third approval for venetoclax, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor, the company said.
BCL-2 is a protein that prevents cancer cells from undergoing apoptosis.
Venetoclax 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, which demonstrated superior progression-free survival (PFS; the time on treatment without disease progression or death) as assessed by investigators in patients treated with venetoclax 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).