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Briefing Materials.pdf

UCM566166.pdf

🔗 Source: fda.gov

📊 Size: 5.18 MB

📄 Pages: 66 pages

⬇️ Downloads: 105

Summary

The FDA Briefing Document for the Oncologic Drugs Advisory Committee Meeting discusses the BLA 125646 for Tisagenlecleucel, a first-in-class product. The proposed indication is for the treatment of pediatric and young adult acute lymphoblastic leukemia (ALL). The document outlines the chemistry, manufacturing, and controls, as well as clinical studies to support efficacy and safety. A Phase II study (B2202) showed promising results, with an overall response rate of 90% and a complete remission rate of 81%. However, safety concerns, such as cytokine release syndrome and neurotoxicity, were also observed. The document highlights the need for risk mitigation strategies and long-term follow-up to monitor potential adverse effects.

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Description

The FDA Briefing Document for the Oncologic Drugs Advisory Committee Meeting discusses the BLA 125646 for Tisagenlecleucel, a first-in-class product.

Technical Information

File Format: PDF
File Size: 5.18 MB
Pages: 66
Language: EN
Total Downloads: 105
Last Updated: 3 weeks ago

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