NICE backs Roche’s Gazyvaro for follicular lymphoma

The cost-watchdog is backing Gazyvaro (obinutuzumab) in combination with bendamustine (chemotherapy) followed by Gazyvaro maintenance for patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab (MabThera) or a rituximab-containing regimen.

The committee concluded that the Gazyvaro-based approach is clinically effective, but were uncertain of its overall survival gain, and so recommended its use in the CDF where further evidence can be collected.

"This decision from NICE is encouraging in terms of the flexibility of the new NICE and Cancer Drugs Fund system, where collecting the right data across a realistic time-frame, in this case four years, is the key to demonstrating the value of Gazyvaro in the long-term," noted Richard Erwin, general manager of Roche UK.

Follicular lymphoma is a type of cancer of the white blood cells and the most common type of indolent non-Hodgkin's lymphoma.

The disease becomes more difficult to treat at each relapse and, if a patient does not respond or relapses during or within six months of a rituximab-containing regimen, they will likely need a different treatment but are left with few options.

Gazyvaro is a 'type II' anti-CD20 monoclonal antibody designed to attack blood cancers more aggressively than 'type I' treatments such as MabThera, shown in clinical trials to significantly reduce the risk of disease progression or death.

The drug’s European approval in the follicular lymphoma setting, secured in June last year, came on the back of data showing that, in patients whose disease progressed during or within six months of prior rituximab-based therapy, those given the Gazyvaro-based regimen experienced a 52 percent reduction in the risk of disease worsening or death compared to bendamustine alone.

Median progression-free survival was more than double that with bendamustine alone (29.2 months vs. 13.7 months), and those taking Gazyvaro also showed a 38 percent reduction in the risk of death.

It’s estimated that 600 new patients per year in the UK who would be eligible to receive Gazyvaro in the relapsed refractory follicular lymphoma indication would benefit from the novel immunotherapy.