Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database

Author:

Fusaroli MicheleORCID,Isgrò Valentina,Cutroneo Paola MariaORCID,Ferrajolo CarmenORCID,Cirillo Valentina,Del Bufalo FrancescaORCID,Raschi EmanuelORCID,Poluzzi ElisabettaORCID,Trifirò GianlucaORCID

Funder

Alma Mater Studiorum - Università di Bologna

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference43 articles.

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2. Hartmann J, Schüßler-Lenz M, Bondanza A, Buchholz CJ. Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts. EMBO Mol Med. 2017;9:1183–97.

3. US FDA. FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma. 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisagenlecleucel-adults-relapsed-or-refractory-large-b-cell-lymphoma. Accessed 26 Jun 2022.

4. US FDA. FDA approves axicabtagene ciloleucel for large B-cell lymphoma. 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-large-b-cell-lymphoma. Accessed 26 Jun 2022.

5. European Medicines Agency. First two CAR-T cell medicines recommended for approval in the European Union. 2018. https://www.ema.europa.eu/en/news/first-two-car-t-cell-medicines-recommended-approval-european-union. Accessed 26 Jun 2022.

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