Roche antibody becomes first of its kind authorised for blood cancer

Specifically, the drug is authorised to be administered with bendamustine followed by obinutuzumab maintenance in those who failed to respond or who progressed during or up to six months after being treated with Roche’s rituximab.

The drug has already seen approval in Europe as of last year, but it was knocked back in the UK last September due to concerns over its benefits to patient’s overall survival. The current decision will provide access for four years through the CDF while Roche builds the trial data needed for a wider approval.

Gazyvaro is a glycol-engineered Type 2 anti-CD20 monoclonal antibody, the first of its kind to be licensed in the blood cancer sphere. The drug targets the CD20 protein found on the surface of B-cells like its close relative rituximab, but Gazyvaro has been engineered to act on cancers more aggressively by modifying the sugars within it. Once attached to the B-cell, the antibody can trigger cell death or turn the body’s immune system on the cell.

"Gazyvaro is one of the first in a series of innovative therapies that are expected to be considered by NICE this year via the new appraisal process for cancer medicines, and it could make a significant difference to patient outcomes across England," explained Richard Erwin, General Manager at Roche UK. "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. 

"We at Roche believe that patients in England should have the best access to medicines in Europe, and this development underlines our commitment to this.  We have worked tirelessly with NICE to ensure that those patients who need Gazyvaro can receive it and we are delighted with this outcome."