🇪🇺 Liso-cel in European Union

EMA authorised Liso-cel on 4 April 2022

Marketing authorisation

EMA — authorised 4 April 2022

  • Application: EMEA/H/C/004731
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Breyanzi
  • Indication: Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.   Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.  Breyanzi is indicated for the treatment of adult patients with relapsed or refractory follicul
  • Pathway: ATMP, PRIME
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Liso-cel approved in European Union?

Yes. EMA authorised it on 4 April 2022.

Who is the marketing authorisation holder for Liso-cel in European Union?

Bristol-Myers Squibb Pharma EEIG holds the EU marketing authorisation.