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BMS wins early UK access for Opdivo in Hodgkin’s lymphoma

Cancer treatment approved by the MHRA for use before EU licence in place

BMSBristol-Myers Squibb's Opdivo has become the first PD-1 inhibitor available to haematological cancer patients in the UK after it was accepted for use through the Early Access to Medicines Scheme (EAMS).

The Medicines Healthcare Products and Regulatory Agency (MHRA) approved Opdivo for early access as a monotherapy for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL) who have already undergone prior therapies for the disease.

Under EAMS the drug's use will be fully-funded by BMS and it can be prescribed in the UK before European regulators, who validated its application in March, come to a decision about licensing this indication.

Benjamin Hickey, general manager, UK and Ireland at Bristol-Myers Squibb, 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.”

The company was, he added, continuing to work with NICE and NHS England to find a solution that would “remove this inequality and enable prompt access for patients in the UK”.

In a recent phase II trial, the immunotherapy considerably reduced tumours in 66.3% of cHL patients who had previously received treatment with Takeda's Adcetris (brentuximab vedotin) and an autologous stem cell transplant (ASCT) - the current standard care.

Meanwhile in the US, the FDA granted Opdivo breakthrough status in cHL after a phase Ib trial showed four patients (17% of the study group) reach complete remission, with a partial response in another 16 patients (70%).

Less common than non-Hodgkin's lymphoma, cHL affects around 12,200 people in the EU every year, and there is a high level of unmet need in UK patients despite EU and US licensing of new therapies.

In the last few months, NICE has rejected Johnson & Johnson's Imbruvica (ibrutinib) and Takeda's Adcetris for treatment of cHL patients in draft guidance citing a lack of cost-effectiveness.

Adcetris - the only licensed medicine for cHL in the UK - had previously been listed on the Cancer Drugs Fund, but is under appraisal as the watchdog reviews all drugs for the new programme.

Article by
Rebecca Clifford

4th November 2016

From: Regulatory



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