🇪🇺 Tecartus in European Union

EMA authorised Tecartus on 14 December 2020

Marketing authorisation

EMA — authorised 14 December 2020

  • Application: EMEA/H/C/005102
  • Marketing authorisation holder: Kite Pharma EU B.V.
  • Local brand name: Tecartus
  • Indication: Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
  • Pathway: conditional, orphan, ATMP, PRIME
  • Status: approved

Read official source →

Tecartus in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Tecartus approved in European Union?

Yes. EMA authorised it on 14 December 2020.

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

Kite Pharma EU B.V. holds the EU marketing authorisation.