NICE has issued a final appraisal for Roche’s Gazyvaro in combination with chlorambucil chemotherapy for the treatment of adults with chronic lymphotic leukaemia (CLL).
Gazyvaro (obinutuzumab) will be a treatment option for adults who are previously untreated or have co-existing medical conditions that mean they are unsuitable for full dose fludarabine- or bendamustine-based therapy.
Jayson Dallas, general manager at Roche UK, commented: “We are very pleased to have worked with NICE to reach a solution whereby patients will soon be able to routinely access Gazyvaro on the NHS in England and Wales.
“The priority is to ensure that commissioners are prepared for the publication of final guidance to follow – at which point they will be responsible for making funding available so that clinicians and their patients can access the drug.”
Data from the CLL11 trial involving eleven UK centres found that Gazyvaro combined with chemotherapy reduced risk of death by 53%, meaning patients remained in remission more than 18 months longer than those receiving chemotherapy alone.
Additionally, more than one in five patients (22.3%) receiving Gazyvaro was in complete remission after treatment, contrasted to no patients in complete remission when receiving the current standard treatment – chemotherapy alone.
Professor John Gribben, professor of medical oncology at Barts Cancer Institute, London, said: “The treatment of CLL has greatly improved over the last ten years, although there still remains a significant unmet need in terms of treatment of the elderly and patients with other health conditions such as diabetes and heart disease, which make them unsuitable to receive the most aggressive treatments.
“The long-awaited decision from NICE to approve Gazyvaro addresses the need for a tolerable and effective treatment option for these patients and is important for both clinicians and their patients in the fight against this common form of blood cancer.”
The news comes after NICE backtracked on its rejection on Gazyvaro in December after initially turning it down due to concerns over the quality of data presented by Roche.