NICE approves first use of Opdivo in blood cancer
NICE has recommended immunotherapy drug nivolumab for the treatment of adult patients with classical Hodgkin lymphoma.
Bristol-Myers Squibb (BMS) has announced that patients in England and Wales who have an aggressive blood cancer will be the first in the UK to benefit from the potentially life-extending medicine, nivolumab, on the NHS. In a reversal of its draft guidance, following review of additional data, the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending the immunotherapy for the treatment of adult patients with classical Hodgkin lymphoma (cHL) whose cancer is progressing (relapsed or refractory) despite prior autologous stem cell transplantation (ASCT) and treatment with brentuximab vedotin (BV). In a single-arm clinical trial, nivolumab caused considerable cancer reduction in over two-thirds of patients, measured as objective response rate (ORR). In addition, 8% of these patients saw a complete response (CR), where no recognisable sign of cancer remained. NICE’s decision means that this important therapy is now available to patients on the NHS.
Dr Graham Collins, Consultant Haematologist, Oxford University Hospitals Foundation Trust, commented: “Today’s decision from NICE will bring immense relief for many patients fighting this aggressive blood cancer. Nivolumab is the first licensed immunotherapy to provide durable response rates, with improved survival in this group of patients, many of whom previously would have faced palliative care. The availability of this much-needed immunotherapy on the NHS will bring a real opportunity for us to improve outcomes for these patients and is a turning point in the treatment of this disease.”
Nivolumab has an innovative mode of action that works by harnessing the ability of the immune system to fight cancer. In a Phase II study, as well as the considerable cancer reduction (ORR) seen, 95% of patients treated with nivolumab were alive one year after treatment. Response rates were durable with a median duration of response of 13.1 months. The trial also showed that nivolumab had an acceptable safety profile with grade 3/4 drug-related adverse events occurring in 29% of patients, the most common were increased lipase (8%), neutropenia (5%), and increased aspartate aminotransferase (4%).
Jonathan Pearce, Chief Executive of the Lymphoma Association, said: “We are delighted to learn that NICE has reversed its initial draft guidance and recommended nivolumab for routine use within the NHS in England and Wales. The decision will bring relief to those Hodgkin lymphoma patients, many of whom are from a younger population, who without this treatment, many would have faced palliative care. It is vital that innovative treatments are being developed and made available to lymphoma patients. We want everyone affected by lymphoma to receive the best possible treatment and care, and the more options there are to improve outcomes and quality of life for patients, the better.”
“We are delighted that NICE has recognised the value of nivolumab in cHL,” said Benjamin Hickey, General Manager, BMS UK and Ireland. “Today’s decision will result in a significant shift in the treatment of patients who have exhausted all available treatment options. The guidance marks the third cancer type for which nivolumab has been recommended by NICE, underscoring its survival benefits in several tumours. While this is positive news for patients with cHL, we remain committed to securing access for all patients across the UK who may benefit from this innovative treatment.”
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