UK patients with a certain form of blood cancer will get access to Bristol-Myers Squibb's immunotherapy Opdivo through the Early Access to Medicines Scheme (EAMS), ahead of its European licence.
Funded by BMS, Opdivo (nivolumab) will be available through the scheme 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.
"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," noted Dr Graham Collins, consultant haematologist, Oxford University Hospitals Foundation Trust.
The decision is based on data from a pivotal Phase II trial published in The Lancet Oncology, which showed that the number of patients treated with the drug - a PD-1 immune checkpoint inhibitor that works by harnessing the ability of the immune system to fight certain types of cancer - demonstrated considerable tumour reduction (objective response rate was 66.3 percent).
Nearly 2,000 people are diagnosed with cHL in the UK each year, mostly adults in their 20s and 30s. The MHRA's decision makes the UK the first country in Europe to allow widespread use of Opdivo on the local health service in this setting.
In England and Wales, since licensing and NICE review, to date, only those patients with advanced (metastatic or unresectable) skin cancer and advanced kidney cancer (after prior therapy) are currently able to receive treatment with Opdivo on the NHS following a positive recommendation by NICE. Access for those with advanced lung cancer is uncertain with draft guidance recommending restrictions that could deny treatment for up to two thirds of patients, the firm noted.
"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, BMS.
"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."