The NHS has approved expanded access to glofitamab (Columvi) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), allowing treatment after just one previous course of therapy rather than requiring two failed treatments. The National Institute for Health and Care Excellence approved the drug today, making it available to approximately 300 patients annually through the NHS Cancer Drugs Fund.
Clinical Efficacy Demonstrates Significant Survival Benefits
Clinical trial data from the STARGLO study reveals compelling efficacy outcomes for glofitamab when combined with gemcitabine and oxaliplatin (GemOx). Almost six in ten patients with late-stage DLBCL achieved complete remission after treatment with the glofitamab combination during clinical trials.
The survival advantage proved substantial in the 24-month follow-up data. More than half (54%) of patients treated with glofitamab remained alive at two years, compared with just over one-third (34%) of those receiving standard treatment with rituximab plus GemOx. Patients treated with glofitamab plus GemOx demonstrated an approximately 42% lower risk of death and a 59% lower risk of disease progression over two years.
Patient Impact and Clinical Experience
Chris Brown, a 70-year-old retired inland waterways captain from Northumberland, exemplifies the treatment's potential impact. Following a stage 4 cancer diagnosis, Brown achieved complete remission by February after glofitamab treatment.
"I never imagined I'd hear the words 'complete remission' after a stage 4 diagnosis, but in February that's exactly what I was told," Brown said. "It gave me a new lease of life – I've been able to enjoy things I thought were lost to me, like spending the summer boating with my family in Sweden."
Dr. Wendy Osborne, a Consultant Haematologist at The Newcastle upon Tyne Hospitals NHS Foundation Trust who treated Brown, emphasized the treatment's clinical significance. "I have patients alive now who would have sadly died from high grade lymphoma if treatments like this had not been fast tracked by the Cancer Drugs Fund," she stated.
Disease Burden and Treatment Landscape
DLBCL represents an aggressive form of non-Hodgkin lymphoma that primarily affects men aged 65 and over, with painless swellings of the glands being the most common symptom. Approximately 5,500 people receive DLBCL diagnoses annually in England. While many patients respond well to initial therapy, survival outcomes remain poor for those whose cancer returns or fails to respond to treatment.
The drug, administered every three weeks via intravenous infusion, targets patients whose lymphoma has returned or not responded to chemotherapy and who are ineligible for autologous stem cell transplant.
Regulatory and Access Framework
Professor Peter Johnson, NHS England's National Clinical Director for Cancer, highlighted the treatment's mechanism and broader implications. "Antibodies such as glofitamab that harness the power of the immune system to target lymphoma, are transforming the way people are treated and helping to boost the number of people cured," he said.
The Cancer Drugs Fund, operational in its current form since July 2016, has facilitated access to innovative cancer treatments for over 108,000 patients. The fund currently helps approximately 1,000 patients monthly access new treatments faster, with over 300 cancer treatment approvals fast-tracked and 50 new options added in the past 18 months alone.
Pia Ballschmieter, UK Haematology Lead at Roche Products Limited, described the approval as "a significant milestone, providing a much-needed option for progressed patients in England and Wales." The company has committed to making the treatment available across the rest of the UK as quickly as possible.
The European Commission previously approved Columvi plus GemOx in April 2025, and Roche has submitted the drug to Scotland's Medicines Consortium, though an assessment date remains pending.
