Opdivo Turned Down By NICE In Head And Neck Cancer
BMS looks unlikely to have a positive NICE opinion synchronized with European approval of Opdivo in head and neck cancer, after the HTA body turned down the checkpoint inhibitor in its draft appraisal.
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The UK HTA NICE in draft guidance has rejected Bristol-Myers Squibb Co.'s Opdivo (nivolumab) as a therapy for previously treated advanced renal cell carcinoma in adults, saying the PD-1 inhibitor doesn't offer value for money. It added that it should also not be made available to such patients through the government-funded Cancer Drugs Fund, for the same reasons.
The UK HTA has recommended Bristol-Myers Squibb's combination therapy of Opdivo and Yervoy to treat patients on the publicly-funded NHS with advanced skin cancer, marking one of the quickest decisions ever from NICE and issued only weeks after the combo was licensed by the EU's European Commission.
Following safety issues raised by the US FDA, no toxicity concerns have emerged in preclinical studies of Newron’s candidate schizophrenia therapy, evenamide, and a clinical safety study has started to evaluate its CNS effects.