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Lisocabtagene maraleucel (new indication: 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), after 1 previous therapy for patients who relapsed within 12 months from completion of, or are refractory to previous therapy)

 

Subject:

  • Active Substance: Lisocaptagene maraleucel
  • Name: Breyanzi®
  • Therapeutic area: B-cell lymphoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH 

 

Time table:

  • Start: 01.06.2023
  • Publication of assessment: 01.09.2023
  • End of public hearing: 22.09.2023
  • Final decision by G-BA: middle of November 2023

 

Comparative therapy:

 

a. Patients with DLBCL, HGBL, PMBCL and FL3B who are eligible for high-dose therapy who relapse or are refractory to first-line therapy within 12 months of completion of first-line therapy: Induction therapy with MINE (mesna, ifosfamide, mitoxantrone, etoposide) followed by high-dose therapy with autologous or allogeneic stem cell transplantation if there is a response to induction therapy.

 

b1. Patients with DLBCL and HGBL who are not eligible for high-dose therapy and who relapse or are refractory to first-line
therapy within 12 months of completion of first-line therapy: therapy at the physician’s discretion choosing from
- Pola-BR (polatuzumab in combination with bendamustine and rituximab) OR
- Tafasitamab + lenalidomide

 

b2. Patients with PMBCL and FL3B who are not eligible for high-dose therapy and who relapse or are refractory to first-line therapy within 12 months of completion of first-line therapy: therapy at the physician’s discretion choosing from
- CEOP (cyclophosphamide, etoposide, vincristine, prednisone) OR
- dose-adjusted EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, prednisone) OR
- monotherapy rituximab (only for patients with FL3B)