NICE recommends Roche biologic for lymphoma

In final guidance, the National Institute for Health and Care Excellence (NICE) has recommended glofitamab as a new treatment option for advanced lymphoma.

The bispecific monoclonal antibody (BsAb) treatment is indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments.

This recommendation coincides with the Medicines and Healthcare Products Regulatory Agency (MHRA) granting a licence for glofitamab.

A novel treatment option for lymphoma

Helen Knight, Director of Medicines Evaluation remarked that it “such good news” that glofitamab was found to be clinically and cost effective for treating people with this advanced form of cancer. NICE “welcome the news that NHS England will make this available to patients quickly,” Knight added. According to NICE, over 700 people could benefit from Roche’s glofitamab.

In July 2023, the treatment was granted conditional marketing authorisation by the European Medicines Agency (EMA) for treating adult patients with DLBCL after two or more lines of systemic therapy.

This approval is based on the positive results obtained from the Phase I/II NP30179 study. Data showed that 35.2 percent of study participants achieved a complete response. NICE noted that clinical trial evidence suggests that some patients given glofitamab attained complete remission with no signs or symptoms of cancer. It also suggests that glofitamab can provide patients with longer survival time and have longer before the disease progresses.

Authorisation by the EMA was preceded by the US FDA approving the treatment in June 2023.

What is glofitamab?

As a t-cell-engaging BsAb, glofitamab is designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is engineered to have one region that binds to CD3 and two regions that bind to CD20. This dual-targeting brings the T-cell close to the B-cell, activating the release of cancer cell-killing proteins from the T-cell.