Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.

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 previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.

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.