NICE says ‘yes’ to new blood cancer drug from Roche

Patients in England and Wales with chronic lymphocytic leukemia (CLL) could soon benefit from Gazyvaro (obinutuzumab), after the medicines cost watchdog the National Institute for Health and Care Excellence (NICE) issued a positive Final Appraisal Determination (FAD) today recommending the drug for routine use on the National Health Service.

Swiss pharma major Roche’s (ROG: SIX) Gazyvaro has been recommended for use in combination with chlorambucil chemotherapy for the treatment of previously-untreated adult patients with CLL and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy, and only if bendamustine-based therapy is also not suitable. This positive determination comes eight months on from the granting of Marketing Authorisation for Gazyvaro in the UK.

Data from the main trial of the drug (CLL11), which involved 11 UK centers, showed that Gazyvaro, combined with chemotherapy, reduced the risk of death by 53% (HR 0.47 95% CI 0.29–0.76, p=0.0014), and meant that patients remained in remission more than 18 months longer than those receiving chemotherapy alone (median progression free survival (PFS) 29.9 months versus 11.1 months, HR 0.18, CI 0.14-0.24, p<0.0001). In addition, more than one in five (22.3%) patients receiving Gazyvaro was in complete remission after treatment. In contrast, no patients achieved complete remission when receiving the current standard, chemotherapy alone.