U.S. Food and Drug Administration Approves Brentuximab Vedotin for Cutaneous T-cell Lymphoma

New York, NY (November 9, 2017) –The U.S. Food and Drug Administration (FDA) announced it has approved the use of brentuximab vedotin (ADCETRIS®) to treat patients with certain types of cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. The antibody-drug conjugate was approved for use in patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF), the two most common subtypes of CTCL.

This approval represents the fourth indication for brentuximab vedotin (ADCETRIS®) after it was granted a Breakthrough Therapy Designation by the FDA in 2016. The anti-CD30 monoclonal antibody had previously been approved for the treatment of classical Hodgkin lymphoma (cHL) patients who had failed autologous hematopoietic stem cell transplantation (auto-HSCT) or who failed at least two prior multi-agent chemotherapy regimens and are not auto-HSCT candidates, patients with cHL at high risk of relapse or progression as post-auto-HSCT consolidation, and systemic anaplastic large cell lymphoma (sALCL) patients who failed at least one prior multi-agent chemotherapy.

Today marks a milestone for those facing a CTCL diagnosis, for whom this approval is an important development,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation.

“Antibody-drug conjugates represent an exciting frontier in lymphoma treatment, particularly for CTCL patients whose treatment options have been historically limited.”

For more information on the FDA approval of brentuximab vedotin (ADCETRIS®), visit https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125388.
For additional information on cutaneous T-cell lymphoma, visit www.lymphoma.org/ctcl.

About the Lymphoma Research Foundation
The Lymphoma Research Foundation (LRF) is the nation’s largest non-profit organization devoted to funding innovative research and serving the lymphoma community through a comprehensive series of education programs, outreach initiatives and patient services. To date, LRF has awarded nearly $60 million in lymphoma-specific research.

For additional information on LRF’s research, education and services, visit lymphoma.org.

Jake DiGregorio