🇪🇺 ZYNYZ in European Union

EMA authorised ZYNYZ on 19 April 2024

Marketing authorisations

EMA — authorised 19 April 2024

  • Application: EMEA/H/C/006194
  • Marketing authorisation holder: Incyte Biosciences Distribution B.V.
  • Local brand name: Zynyz
  • Indication: Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC)  Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.
  • Pathway: orphan
  • Status: approved

The European Medicines Agency (EMA) approved ZYNYZ for use in the European Union on 19 April 2024. ZYNYZ is indicated for the treatment of two types of cancer: squamous cell carcinoma of the anal canal (SCAC) and Merkel cell carcinoma (MCC). For SCAC, ZYNYZ is used in combination with carboplatin and paclitaxel for first-line treatment of adult patients with metastatic or inoperable locally recurrent SCAC. For MCC, ZYNYZ is used as monotherapy for first-line treatment of adult patients with metastatic or locally advanced MCC not amenable to curative surgery or radiation therapy.

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EMA

  • Application: EMEA/H/C/005632
  • Marketing authorisation holder: Incyte Biosciences Distribution B.V.
  • Local brand name: Zynyz
  • Indication: Treatment of locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy
  • Status: withdrawn

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ZYNYZ in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is ZYNYZ approved in European Union?

Yes. EMA authorised it on 19 April 2024; EMA has authorised it.

Who is the marketing authorisation holder for ZYNYZ in European Union?

Incyte Biosciences Distribution B.V. holds the EU marketing authorisation.