EU/3/18/2013: Orphan designation for the treatment of diffuse large B-cell lymphoma
Table of contents
On 16 April 2018, orphan designation (EU/3/18/2013) was granted by the European Commission to Roche Registration Limited, United Kingdom, for polatuzumab vedotin for the treatment of diffuse large B-cell lymphoma.
The sponsorship was transferred to Roche Registration GmbH., Germany, in July 2018.
Polatuzumab vedotin has been authorised in the EU as Polivy since 16 January 2020.
The medicinal product has been authorised in the EU as Polivy since 24 May 2022.
Treatment of diffuse large B-cell lymphoma
|Orphan designation status||
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Roche Registration GmbH
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Polivy at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the orphan medicine assessment report .
Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: