From today patients in Scotland with chronic lymphocytic leukaemia (CLL) have gained ‘routine’ access to a new treatment option after cost-regulators approved Roche’s Gazyvaro (obinutuzumab) for National Health Service use in the country.
Gazyvaro is the first ‘type II’ anti-CD20 monoclonal antibody licensed for the treatment of CLL and is designed to attack blood cancers more aggressively than ‘type I’ treatments such as MabThera (rituximab).
According to the Swiss drugmaker, the drug has a double-pronged mode of attack being able to kill cancer cells directly as well as alert the body’s immune system to ‘enemy’ cancer cells, thereby boosting the immune response.
Specifically, Gazyvaro has been recommended by the Sottish Medicines Consortium for use in combination with chlorambucil chemotherapy for the treatment of previously-untreated patients with CLL and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy.
Clinical data from a key study, conducted in Scotland, helped secure the decision, showing that Gazyvaro/chemotherapy cut the risk of death by 59% and boosted progression-free survival by 15 months versus chemo alone, while 22.3% of patients were in complete remission compared to none of those in the control arm.
On the safety side, Roche says the drug has a “manageable tolerability profile” with the most common adverse events being infusion-related reactions, 21% of which were severe. Others reported were neutropenia (35%), low platelet count (thrombocytopenia) (11%), infections (11%), anaemia (5%) and leukopenia (5%).
The SMC decision closely follows a National Institute for Health and Care Excellence draft guidelines recommending use of Gazyvaro on the NHS in England.