Lisocabtagene Maraleucel

Form: IV Infusion

Strength: Approved for relapsed/refractory large B-cell lymphoma, with a standard dose of 100 million CAR T cells per infusion

Reference Brands: Breyanzi (US & EU)

Category: Cell & Gene Therapies

Lisocabtagene maraleucel (Breyanzi) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in accordance with GMP and MDR standards. In the US, FDA approval involved rigorous clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR. The product undergoes validation, stability testing, and audits, with comprehensive documentation including clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to innovative CAR T-cell therapies supporting treatment of relapsed/refractory lymphomas worldwide, improving patient outcomes and quality of life.