Bristol Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, when a stem cell transplant is suitable.

From today, eligible patients in England will have access to lisocabtagene maraleucel as a treatment option, via routine commissioning*. The decision follows regulatory authorisation of lisocabtagene maraleucel in October 2023 by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

“This recommendation provides an alternative treatment option for eligible patients who may have limited choices and helps to address an unmet need for these patients, their families, carers and clinicians.” said Dallas Pounds, Director of Services at Lymphoma Action. “At Lymphoma Action, we see
the daily challenges faced by those living with lymphoma. Advancements like this highlight the importance of continued innovation in lymphoma care, giving patients access to important therapies. Lymphoma Action is committed to providing trusted information and support to the thousands of people affected by lymphoma in the UK.”

Large B-cell lymphomas (LBCLs) are a type of non-Hodgkin lymphoma (NHL). They are a cancer of the immune system, characterised by abnormal growth of B-cells leading to tumours in the lymph nodes and elsewhere in the body.

In 2020, 4,209 people in England had a diagnosis of DLBCL, which equates to about 40% of those diagnosed with NHL. HGBCL, PMBCL and FL3B are rarer subtypes of NHL, accounting for 4-6% of global NHL cases.

Most people diagnosed with DLBCL are 65 or over. Although most people are cured with first-line chemotherapy, about 10-15% have primary refractory
disease (where the cancer has not responded or has stopped responding to treatment) and a further 20-30% relapse.

Survival rates at 5 years for relapsed DLBCL are around 30%. People with relapsed or refractory LBCL tend to have a poorer prognosis compared with those with newly diagnosed disease.

“The recommendation of lisocabtagene maraleucel is important news for people living with lymphoma in England and Wales,” said Professor Andrew Davies, investigator on the TRANSFORM study and Chair for the UK Lymphoma Study Group. “It offers eligible patients another treatment option, made from cells of the patient’s own immune system, which have been genetically modified to recognise and attack their lymphoma cells.

This treatment offers an alternative option to those whose lymphoma has returned or is not responding to initial treatment. It is a testament to the progress we are making in cancer care, including access to CAR T for patients with more rare lymphoma sub-types.”

The decision is supported by data from the Phase 3 TRANSFORM trial which compared lisocabtagene maraleucel with reinduction chemotherapy followed by high-dose chemotherapy (HDCT) and haematopoietic stem cell transplant (HSCT) in patients with large B-cell lymphomas that were primary refractory or relapsed within 12 months after CD20-antibody and anthracycline containing first-line therapy. 184 patients were enrolled in this trial.

Source: Bristol Myers Squibb