Bristol-Myers Squibb cancer immunotherapy Opdivo approved in EU

pharmafile | April 13, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Bristol-Myers Squibb, Cancer, EU, NICE, approval, immunotherapy, opdivo 

Bristol-Myers Squibb has announced that its potentially life-extending cancer immunotherapy, Opdivo (nivolumab), has been approved by the European Commission to treat patients with the most common forms of advanced lung and advanced kidney cancer.

The drug had previously been made available through the Early Access to Medicines Scheme in the UK, and this approval in the EU expands its capability to address an unmet need in both advanced lung and advanced kidney cancers.

The current label for nivolumab will now be expanded to include the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer after prior chemotherapy, as well as adult patients with advanced renal cell carcinoma who have received prior therapy.

These forms of cancers make a large contribution to overall deaths from cancer, with survival rates poor in advanced cases. In 2012, 35,000 deaths were attributable to lung cancer while 4,300 died from kidney cancer. In advanced stages, only 5-10% of patients survive beyond five years with these cancers.

Professor Dean Fennell, chair of thoracic medical oncology at the University of Leicester, comments: “The launch of nivolumab will irrevocably change the treatment of this condition and represents one of the biggest advances in almost two decades. Treating these patients as quickly as possible is vital so we hope access will be as prompt as possible across the UK.

Johanna Mercier, general manager at BMS UK & Ireland, says: “We are pleased that European regulatory bodies have once again recognised the value of nivolumab to cancer patients and the unmet need that this life-extending medicine addresses. However, it is important to note that patients in the UK will not have access to nivolumab until reimbursement authorities have reviewed the evidence.

“This review process is already progressing for non-squamous NSCLC patients, with the first NICE committee meeting taking place today. We are committed to supporting the review and will do everything in our power to find a rapid solution for these patients.”

Sean Murray

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