Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that CD30 + status confers therapeutic sensitivity to Brentuximab Vedotin in patients with Anaplastic Large Cell Lymphoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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.