Idecabtagene Vicleucel

Form: IV Infusion

Strength: Approved for relapsed/refractory multiple myeloma, with dosing based on patient weight, delivering a personalized, targeted therapy to eliminate cancer cells

Reference Brands: Abecma(US & EU)

Category: Cell & Gene Therapies

Idecabtagene vicleucel (Abecma) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in line with GMP and MDR standards. FDA approval involved extensive clinical validation, safety assessment, and comparability data. In the EU, CE marking certifies conformity with MDR regulations. The product undergoes validation, stability testing, and audits, with comprehensive documentation including clinical trial results, 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 CAR T-cell therapies for multiple myeloma and other hematologic malignancies globally, supporting improved patient outcomes and advanced cancer care.