Breakthrough immunotherapy for blood cancer becomes available to UK patients
First early access scheme for breakthrough immunotherapy in blood cancer.
Bristol-Myers Squibb (BMS) has announced that the Medicines Healthcare Products and Regulatory Agency (MHRA) has granted UK patients with one form of blood cancer access to the investigational medicine, nivolumab, through the Early Access to Medicines Scheme (EAMS), ahead of its European licence. Through the EAMS and funded by BMS, nivolumab will be available as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
“Today’s [4 November 2017] decision will be very welcome news for clinicians and patients in the UK because it means that patients with classical Hodgkin lymphoma will have early access to nivolumab, a treatment that uses the body’s own immune system to fight the cancer,” said Dr Graham Collins, Consultant Haematologist, Oxford University Hospitals Foundation Trust. “For patients whose disease has progressed after initial therapy, treatment options have previously been limited. From today, these sick and often young patients will potentially be able to benefit from this new and effective medicine which we hope will provide longer survival in these patients.”
The first step towards an EAMS is the awarding of a Promising Innovative Medicine (PIM) status and this is the fifth time nivolumab has been awarded such a status and been granted an EAMS. The latest EAMS decision by the MHRA is based on the strength of the pivotal Phase II data published in The Lancet Oncology, which showed that the number of patients treated with nivolumab with considerable tumour reduction (objective response rate) was 66.3%.
Jonathan Pearce, Chief Executive of the Lymphoma Association, said: “It is vital that innovative treatments being developed are 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 to provide nivolumab to patients with classical Hodgkin lymphoma through the EAMS. However, despite it being consistently recognised as an innovative treatment, the majority of patients with advanced lung cancer may be denied access to nivolumab with a recent recommendation from NICE proposing treatment be restricted to only a third of patients – something which is inconsistent with clinical evidence,” said Benjamin Hickey, General Manager, UK and Ireland, Bristol-Myers Squibb. “We are continuing to work with NICE and NHS England to find a solution that will remove this inequality and enable prompt access for patients in the UK.”
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