NICE backs chemo-free CLL combination from AbbVie and Roche

Previously untreated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of AbbVie’s Venclyxto and Roche’s Gazyva.

The decision by NICE allows for the 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial.

This showed the combination of Venclyxto (venetoclax) and Gazyva (obinutuzumab) had superior progression-free survival and sustained that benefit after stopping treatment compared with those receiving a commonly used chemoimmunotherapy regimen of Gazyva and chlorambucil chemo.

NICE recommended the combination in patients with del(17p)/TP53 mutation and those without del(17p)/TP53 mutation for whom fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR) are unsuitable.

The cost-effectiveness body also recommended the combination for use within the Cancer Drugs Fund (CDF) for patients without del(17p)/TP53 mutation and for whom FCR or BR are suitable, subject to a managed access agreement.

The combination therapy will be available to NHS patients in England immediately.

CLL is the most common type of chronic blood cancer, with around 10 new patients diagnosed every day.

Unlike some cancers, CLL has a highly variable clinical course so patients are usually left to ‘watch and wait’, after which some patients will be offered appropriate treatment.

However, despite novel therapeutic advancements in CLL, the disease remains incurable and patients will often relapse following treatment.

Professor Peter Hillmen, consultant in clinical haematology at Leeds Teaching Hospitals and honorary professor of haematology at University of Leeds, said that the treatment can produce a “deep response.”

“Ultimately, this has the potential to improve patients’ quality of life and reduce the significant burden of therapy,” he added.

The European Commission approved the combination therapy for the treatment of for adult patients with previously untreated chronic lymphocytic leukaemia in March 2020.

Venetoclax is being developed by AbbVie and Roche. It is jointly marketed by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US.