EMA Recommends Extension of Therapeutic Indications for Polatuzumab Vedotin

On 24 March 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 polatuzumab vedotin (Polivy).

The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

 The CHMP adopted a new indication for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL).

For information, the full indications for Polivy will be as follows (new indication in bold):

Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated DLBCL.

Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory DLBCL who are not candidates for haematopoietic stem cell transplant.

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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