Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to brentuximab vedotin for the 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 as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD30 +	Anaplastic Large Cell Lymphoma	Brentuximab Vedotin