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UK's NICE Recommends Venclyxto, Gazyva for Chronic Lymphocytic Leukemia

NEW YORK – The UK's National Institute for Health and Care Excellence published a final draft guidance on Tuesday recommending venetoclax (AbbVie's Venclyxto) plus obinutuzumab (Roche's Gazyva) without chemotherapy for untreated chronic lymphocytic leukemia (CLL) patients with certain genetic mutations.

The agency said the UK National Health Service should make venetoclax plus obinutuzumab available for untreated CLL patients if they have a 17p deletion or TP53 mutation. For patients without these mutations, NICE recommended the combination treatment only if they cannot receive a regimen of rituximab (Genentech/Biogen's Rituxan), fludarabine, and cyclophosphamide or rituximab plus bendamustine.

NICE also recommended the combination treatment to be included in the Cancer Drugs Fund, which will allow the group to collect more evidence on the treatment's cost effectiveness.

The agency based its decision on a clinical trial that compared venetoclax plus obinutuzumab to obinutuzumab plus the chemotherapy chlorambucil. That trial showed significant improvement in progression-free survival for the venetoclax-obinutuzumab combination.

The companies also submitted an indirect comparison of the treatment in CLL patients with a 17p deletion or TP53 mutation. That data compared the combination treatment to ibrutinib (AbbVie's Imbruvica) and found no statistically significant difference in progression-free survival or overall survival.

The price for a 112-pack of 100-mg venetoclax tablets is £4,789 ($6,330) and the price for a 100-mg vial of obinutuzumab is £3,312 ($4,380). The NHS will receive both drugs at an undisclosed discount.