The Medicines Healthcare Products and Regulatory Agency (MHRA) has granted US-based 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.
Funded by Bristol-Myers Squibb (BMS) and through the EAMS, nivolumab will be available as monotherapy to treat adult patients with relapsed or refractory classical hodgkin lymphoma (CHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Oxford University Hospitals Foundation Trust consultant haematologist Dr Graham Collins said: "The 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.”
“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 move towards an EAMS is the receipt of a Promising Innovative Medicine (PIM) status.
This is the fifth time that nivolumab has been granted such a status and an EAMS.
The latest EAMS decision by the MHRA is based on the Phase II data, which indicated that the number of patients treated with nivolumab and tumour reduction in objective response rate (ORR) was 66.3%.
Lymphoma Association chief executive Jonathan Pearce 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.”
Nivolumab belongs to a class of medicines called PD-1 immune checkpoint inhibitors and works by leveraging the immune system's ability to fight certain types of cancer, including classical hodgkin lymphoma (CHL), advanced lung, skin and kidney cancer. It is presently being investigated in several other types of cancer.
Through the EAMS, BMS has allowed more than 370 patients with advanced lung and kidney cancer to access nivolumab ahead of marketing authorisation.
Following receipt of a licence, the EAMS closes to new patients and further access is only available through positive health technology assessment guidance in England, potentially including funding through the Cancer Drugs Fund.
To date, since licensing and NICE review in England and Wales, only those patients with advanced (metastatic or unresectable) skin cancer and advanced kidney cancer (after prior therapy) are currently able to receive treatment with nivolumab on the NHS following a positive recommendation by NICE.
Access to nivolumab for NHS patients in England and Wales who have advanced lung cancer remains uncertain, with draft NICE guidance recommending restrictions that could deny treatment for up to two thirds of patients.
Bristol-Myers Squibb general manager for UK and Ireland Benjamin Hickey said: “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.
“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.”