Breyanzi (lisocabtagene maraleucel)
- Region
- 🇪🇺 EU
- Active substance
- lisocabtagene maraleucel
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
- CHMP opinion
- Thu 27 Jan 2022
- EU approval
- Mon 04 Apr 2022
- Designations
- PRIME, ATMP, Additional monitoring
- Application
- EMEA/H/C/004731
- ATC
- L01XL08
- Official record
- www.ema.europa.eu
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 follicular lymphoma (FL) after two or more lines of systemic therapy. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.