Posted by Michael Wonder on 06 May 2020
AbbVie receives Health Canada approval for the combination of Venclexta (venetoclax) with obinutuzumab for patients with previously untreated chronic lymphocytic leukaemia
5 May 2020 - Venclexta (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukaemia.
AbbVie announced today that Health Canada has approved Venclexta (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of Venclexta.
Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with Venclexta had clinically meaningful and statistically significant progression-free survival and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemo-immunotherapy regimen of obinutuzumab and chlorambucil.
