NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years
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The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung whose disease has progressed after prior chemotherapy.
Bristol-Myers Squibb (BMS0 has announced that the National Institute for Health and Care Excellence (NICE) has issued draft guidance for consultation that could prevent NHS patients with a form of lung cancer, from receiving Opdivo (nivolumab). The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung (NSCLC) whose disease has progressed after prior chemotherapy. In a pivotal clinical study, treatment with nivolumab was shown to achieve significantly superior survival rates, with 42% of patients still alive at one year compared with 24% of those treated with docetaxel. If this becomes final guidance, it will mean that treatment options for these patients will remain limited to chemotherapies, such as docetaxel which was first approved for use 17 years ago. Lung cancer is one of the UK’s biggest health challenges, with survival rates that lag almost a decade behind some European countries.
Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland, said: “Today’s draft decision is deeply disappointing for lung cancer patients and for us as we have worked extensively with the UK Health Authorities to enable prompt patient access to nivolumab. We have made this pioneering medicine available both through our clinical trial programme and through the Early Access to Medicines Scheme. We are continuing to work with NICE to facilitate access for patients who urgently need it.”
Nivolumab is the first in a new class of medicines, called PD-1 immune checkpoint inhibitors, to be licensed for use in squamous pre-treated lung cancer patients. It has an innovative mode of action that works by harnessing the ability of the immune system to find and fight cancer.
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