BMS’ Opdivo gains early access approval in kidney cancer

Bristol Myers Squibb’s Opdivo has been added to the UK’s Early Access to Medicines Scheme (EAMS) for patients with renal cell carcinoma.

EAMS is a special early access route, allowing doctors to prescribe the most promising new treatments for life threatening conditions before they gain European marketing authorisation for the indication.

There have been seven EAMS decisions since the scheme was launched in 2014, and the latest decision means that no fewer than four of these have been for Opdivo.

Opdivo received the same early access status in melanoma in 2015, then squamous non-small cell lung cancer (NSCLC) and non-squamous NSCLC.

While the scheme allows rapid uptake of the drug in a small number of patients there is, however, no guarantee it will translate into full access across the UK.

Opdivo gained NICE approval for use in melanoma, but has seen its use in squamous NSCLC rejected in draft guidance, the cost-effectiveness body citing its high cost.

UK’s regulator the Medicines Healthcare Products and Regulatory Agency (MHRA) based its decision on a phase 3 clinical trial comparing Opdivo to the current standard of treatment – everolimus (Afinitor). The study found the drug produced an overall median survival benefit of 5.4 months compared to patients who had already received prior therapy for advanced kidney cancer.

Opdivo is at the forefront of immuno-oncology, and is battling with Merck’s rival PD-1 inhibitor Keytruda for dominance in the market. Merck’s drug was the first drug to be granted EAMS status, and then gained an extra-rapid NICE approval for melanoma patients in September last year.

James Larkin, consultant medical oncologist at the Royal Marsden welcomed the MHRA’s latest decision, emphasising the fact that Opdivo is the first immunotherapy to demonstrate a significant improvement in kidney cancer survival compared to standard therapy.

BMS welcomed the decision, but also drew attention to the NICE ruling on squamous NSCLC.

Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland said: “Bristol-Myers Squibb has worked in collaboration with the MHRA to ensure early access to nivolumab, this time in patients with kidney cancer.

“Recent draft guidance issued by NICE not recommending nivolumab for squamous lung cancer patients is disappointing, however, we are hopeful that health bodies in the UK will recognise nivolumab for its value, innovation and advantageous survival benefit for patients, and ensure prompt reimbursement as soon as possible across all licensed indications.”

Opdivo is still some months away from being approved Europe for renal cell carcinoma, with Europe’s EMA beginning its review of the data in November. The US FDA has moved faster, however, approving its use in these patients in November via a breakthrough therapy designation.