U.S. Food and Drug Administration Approves Brentuximab Vendotin For Frontline Hodgkin Lymphoma

New York, NY (March 20, 2018) –The U.S. Food and Drug Administration (FDA) announced it has approved the use of brentuximab vedotin (ADCETRIS®) in combination with chemotherapy for the treatment of adults with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL). This indication marks the first new approval for the frontline treatment of advanced stage classical Hodgkin lymphoma in more than 40 years.

“Today’s approval of brentuximab vedotin is a historic approval that represents a new treatment option for patients and their loved ones who are dealing with a late-stage classical Hodgkin lymphoma diagnosis,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We applaud the FDA and Seattle Genetics for their leadership in advancing the standard of care for cHL patients, as well as the patients and researchers who made this advancement possible; we are hopeful that this approval will lead to improved outcomes in the Hodgkin lymphoma community.”

Today’s announcement represents the fifth approval of brentuximab vedotin (ADCETRIS®) in the treatment of lymphoma. Prior indications include the use of the antibody-drug conjugate to treat: classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, systemic anaplastic large cell lymphoma sALCL after failure of at least one prior multi-agent chemotherapy regimen, and primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

According to the Lymphoma Research Foundation’s website, approximately 9,000 new cases of Hodgkin lymphoma are projected each year. To learn more about Hodgkin lymphoma or to download the Foundation’s Hodgkin lymphoma Booklet or Fact Sheet, please visit LRF’s newly redesigned website at https://www.lymphoma.org/hl/