Regulatory approval

Published by the Food and Drug Administration. Approved

ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

This is written in the approval document.

Citation

Seagen Inc. Adcetris (brentuximab vedotin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125388s107lbl.pdf. Revised June 2023. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CD30 +	Anaplastic Large Cell Lymphoma	Brentuximab vedotin

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-06-14	Food and Drug Administration	Indication received traditional approval.