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nivolumab (Opvido)

Advice

following a full submission considered under the end of life and orphan equivalent process:

nivolumab (Opdivo®) is not recommended for use within NHS Scotland.

Indication under review: nivolumab as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

In a single arm, phase II study of patients with metastatic, or surgically unresectable, urothelial carcinoma with progressive disease on or after platinum based chemotherapy, treatment with nivolumab resulted in an objective response in 20% of patients. 

The submitting company did not present a sufficiently robust economic and clinical analysis to gain acceptance by SMC. 

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Drug Details

Drug Name: nivolumab (Opvido)
SMC Drug ID: 1285/18
Manufacturer: Bristol-Myers Squibb Pharmaceuticals Ltd
Indication: nivolumab as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. In a single arm, phase II study of patients with metastatic, or surgically unresectable, urothelial carcinoma with progressive disease on or after platinum based chemotherapy, treatment with nivolumab resulted in an objective response in 20% of patients.
BNF Category:
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 15 January 2018

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