The National Institute for Health and Care Excellence has now issued final guidance rejecting NHS funding for use of Bristol-Myers Squibb’s Opdivo as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (mUC).
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Bristol-Myers Squibb’s Opdivo has picked up approval for its eighth indication in Europe, having won clearance for the treatment of a subset of patients with metastatic urothelial carcinoma (mUC).
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Merck and Pfizer have announced a second accelerated approval in the US for Bavencio in less than two months, in this instance for certain patients with metastatic urothelial carcinoma.
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Roche’s immunotherapy Tecentriq has failed to significantly improve overall survival compared to chemotherapy in pre-treated patients with advanced bladder cancer, marking a major setback for the drug.
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AstraZeneca has secured accelerated approval in the US for its immunotherapy Imfinzi as a treatment for certain patients with advanced bladder cancer.
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The US Food and Drug Administration has expanded the approval of Roche’s Tecentriq so that it can be used to treat a wider range of patients with bladder cancer.
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The US Food and Drug Administration has approved Bristol-Myers Squibb’s immunotherapy Opdivo as a treatment for the most common form of bladder cancer.
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Roche’s Tecentriq has been accepted onto the UK’s Early Access to Medicines Scheme (EAMS), having picked up a positive scientific opinion from the Medicines and Healthcare products Regulatory Agency for the treatment of bladder cancer.
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Bristol-Myers Squibb’s immunotherapy Opdivo has taken big step towards European approval in bladder cancer, after regulators validated the firm’s marketing application, kick-starting the European Medicines Agency’s centralised review process.
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Roche’ bladder cancer drug Tecentriq shrank tumours in 24 percent of patients previously untreated for the disease, raising hopes that it might be approved in the first-line setting.
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