On 21 March 2016, orphan designation (EU/3/16/1624) was granted by the European Commission to Acerta Pharma, BV, the Netherlands, for acalabrutinib for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma.
The sponsorship was transferred to AstraZeneca AB, Sweden, in October 2019.
Please note that this product (marketed as Calquence ) was withdrawn from the Union Register of orphan medicinal products in September 2020 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
|Disease / condition||
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
|Date of first decision||
|EU designation number||
Review of designation
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance .
Sponsor's contact details
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.