Axicabtagene Ciloleucel

Form: IV Infusion

Strength: Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight

Reference Brands: Yescarta (US & EU)

Category: Cell & Gene Therapies

Axicabtagene ciloleucel (Yescarta) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These CAR T-cell therapies undergo validation, stability testing, and audits, with detailed 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, life-saving immunotherapies supporting advanced cancer treatments worldwide.