EU/3/21/2518: Orphan designation for the treatment of pancreatic cancer

paclitaxel / polyoligo(ethylene glycol)methacrylate-co-poly(vinylbenzyldithiodibutyric acid-gemcitabine)

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This medicine was designated as an orphan medicine for the treatment of pancreatic cancer in the European Union on 12 November 2021.

This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.

Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.

During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:

Key facts

Active substance
  • paclitaxel
  • polyoligo(ethylene glycol)methacrylate-co-poly(vinylbenzyldithiodibutyric acid-gemcitabine)
Intended use
Treatment of pancreatic cancer
Orphan designation status
EU designation number
Date of designation

Duo Oncology Europe B.V.
Floor 2nd
De Cuserstraat 93
1081 CN Amsterdam

Update history

December 2021Sponsorship transferred from Karma Oncology B.V. to Duo Oncology Europe B.V, The Netherlands.

Documents related to this orphan designation evaluation

Patients' organisations

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:

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