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EMA Recommends Extension of Therapeutic Indications for Nivolumab

New indications concern the treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma and the adjuvant treatment of muscle invasive urothelial carcinoma
07 Mar 2022
Cancer Immunology and Immunotherapy;  Gastrointestinal cancers;  Genitourinary cancers

On 24 February 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product nivolumab (Opdivo).

The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted new indications as follows:

Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.

Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.

Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

On 24 February 2022, the EMA’s CHMP adopted also a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ipilimumab (Yervoy).

The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted a new indication as follows:

Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.

Detailed recommendations for the use of these products will be described in the updated summaries of product characteristics, which will be published in the revised European public assessment reports, and will be available in all official European Union languages after a decision on these changes to the marketing authorisations have been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.

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