EMA Recommends Extension of Indications for Avelumab

On 10 December 2020, 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 avelumab (Bavencio).

The marketing authorisation holder for this medicinal product is Merck Europe B.V.

The CHMP adopted a new indication as follows (new text in bold):

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma.

Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.

Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has 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 opinion.

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