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NICE Approves Glofitamab (Columvi) for Aggressive Lymphoma

Hundreds of people in England with diffuse large B-cell lymphoma (DLBCL) could benefit from a new treatment option following approval of the drug glofitamab ( Columvi, Roche).

Around 5500 people are diagnosed with diffuse (DLBCL) — a type of non-Hodgkin lymphoma — in England each year. The disease mainly affects men aged 65 and over, with the most common symptom being painless swellings of the glands. 

Currently, patients with DLBCL may receive treatment with a combination of chemotherapy, radiotherapy, bone marrow transplant, and chimeric antigen receptor (CAR) T-cell therapies. However, in many cases the disease is refractory.

Helen Knight, director of medicines evaluation at the National Institute for Health and Care Excellence (NICE), alerted that the cancer "can progress quickly". She stressed that "the sooner people can access the best treatment for them, the better chance they have of living for longer and improving their quality of life".

Life-Changing Breakthrough

Glofitamab is a bispecific monoclonal antibody. It attaches to a specific protein on the surface of B cells, including cancerous B cells, and also to another protein on the surface of T cells, triggering the activation and multiplication of T cells. The result is the "destruction of the B cells, including the cancerous cells".

"Bispecific antibodies use the patient's own white blood cells to attack and kill the lymphoma," explained Dr Wendy Osborne, consultant haematologist specialising in lymphoma at the Freeman Hospital in Newcastle. "The antibody has two arms. One arm attaches to the cancer cell and the other to the patient's own white blood cell, a T-cell. By bringing these cells together, the patient's own immune system is activated and kills the cancer cell and so chemotherapy is not required."

According to Dr Osborne, an NHS rollout of bispecific antibodies like glofitamab was set to be a "breakthrough" for patients with lymphoma, and had already "proven to be life-changing". She added that patients don't have the side effects of chemotherapy and often feel well on the outpatient-based treatment.

Complete Remission Possible

Final guidance recommending glofitamab for NHS use in England coincided with the drug receiving a licence from the Medicines and Healthcare products Regulatory Agency (MHRA).

As a result, NHS England said glofitamab "will be made available within weeks for patients who have had two or more cancer treatments that have not been fully effective in eliminating their cancer". It said it would use the Cancer Drugs Fund "to provide fast-tracked access to the treatment ahead of its future funding from routine commissioning". 

According to NICE, more than 700 people were set to benefit from new treatment option.

Clinical trial evidence presented to its appraisal committee suggested that some people taking glofitamab reached "complete remission with no signs or symptoms of cancer", and that people could live longer and have longer before their condition deteriorated.

Treatment Closer to Home

CAR T therapies are already provided in specialist centres across England, emphasised NHS England. However, glofitamab, which is administered as an intravenous infusion, could be offered at "more cancer treatment sites" across the country, it pointed out.

Professor Peter Clark, NHS England's Cancer Drugs Fund lead, said approval was "great news" for patients with the disease. "Not only does it provide a potentially life-saving option for patients who may have not responded to CAR T therapy, it is also an alternative for some CAR T eligible patients who choose instead to have glofitamab closer to home," he said.

Asked to comment by Medscape News UK, Dallas Pounds, director of services at Lymphoma Action welcomed the announcement for offering "new hope" to people with relapsed diffuse large B-cell lymphoma.

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Editor's note: This article was updated on 19 October to include a comment from Lymphoma Action.