Hodgkin Lymphoma: FDA Updates

November 11, 2022 – The U.S. Food and Drug Administration (FDA) approved the use of brentuximab vedotin (Adcetris), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high-risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin. More information

March 20, 2018 – The U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (ADCETRIS) in combination with chemotherapy for the treatment of adult patients with previously untreated stage  III or IV classical Hodgkin. This is the first FDA-approved therapy in frontline stage III or IV classical Hodgkin lymphoma in more than 40 years. More information.

August 2, 2017 – The U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. More information.

March 14, 2017 – The U.S. Food and Drug Administration (FDA) approved the use of pembrolizumab (KEYTRUDA®) for refractory classical Hodgkin lymphoma, or patients who have failed at least three prior therapies. More information.

May 17, 2016 – The U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the treatment of classical Hodgkin lymphoma patients who have relapsed or progressed after an auto transplant and brentuximab vedotin. More information.

March 30, 2016 – The U.S. Food and Drug Administration approved defibrotide sodium (DEFITELIO) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). More information.

August 18, 2015 – The U.S. Food and Drug Administration (FDA) has approved brentuximab vedotin (ADCETRIS) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous stem cell transplantation consolidation. More information.

August 19, 2011 – The United States Food and Drug Administration (FDA) approved brentuximab vedotin (ADCETRIS) for the treatment of patients Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. It is an antibody-drug conjugate that combines an antibody and cytotoxic agent, allowing the antibody to direct the drug to a target on the surface of lymphoma cells known as CD30. Brentuximab vedotin is the first FDA-approved new treatment for Hodgkin lymphoma since 1977. More information.