Opdivo

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Questions & Answers

On 25 February 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions recommending changes to the terms of the marketing authorisation for the medicinal product Opdivo. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted a new indication as follows:

'Renal Cell Carcinoma (RCC)

Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.'

In addition, the CHMP adopted an extension to an existing indication as follows1:

'Opdivo is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.'

For information, the full indications for Opdivo will be as follows:

Melanoma

Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Non-Small Cell Lung Cancer (NSCLC)

Opdivo is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)

Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.


1 Removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Opdivo (II/0002) (English only) 26/02/2016  

Key facts

Product details for Opdivo
NameOpdivo
INN or common name

nivolumab

Therapeutic area Melanoma
Active substance

nivolumab

Date opinion adopted25/02/2016
Company name

Bristol-Myers Squibb Pharma EEIG

StatusPositive
Application typePost authorisation

Relaed content