On 30 May 2016, orphan designation (EU/3/16/1667) was granted by the European Commission to Aceso Biologics Consulting Ltd, United Kingdom, for rovalpituzumab tesirine for the treatment of small cell lung cancer.

The sponsorship was transferred to Abbvie Ltd, United Kingdom, in February 2017 and subsequently to AbbVie Deutschland GmbH & Co. KG, in May 2018.

Key facts

Active substance
Rovalpituzumab tesirine
Disease / condition
Treatment of small cell lung cancer
Date of decision
Orphan decision number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

AbbVie Deutschland GmbH & Co. KG
67061 Ludwigshafen
Tel. +49 621 589 3382

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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