Anaplastic Large Cell Lymphoma: FDA Updates

January 14, 2021 – The U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).  This is the first biomarker-driven therapy approved for pediatric ALCL. More information.

November 16, 2018 – The U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (ADCETRIS) injection in combination with chemotherapy for adult patients with previously untreated systemic anaplastic large cell lymphoma (ALCL) and other CD30-expressing peripheral T-cell lymphoma (PTCL). This is the first FDA approved frontline treatment for PTCL. More information.

November 9, 2017 – The U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.  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 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.

January 27, 2015 – The U.S. Food and Drug Administration (FDA) approved a same-day delivery device for pegfilgrastim (Neulasta) for non-Hodgkin lymphoma patients who do not need to return to the clinic the day after chemotherapy. More Information.

October, 19, 2012 – The U.S. Food and Drug Administration (FDA) approved a 90-minute infusion for rituximab (Rituxan Injection) starting at Cycle 2 for patients with non-Hodgkin’s lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during Cycle 1. Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (>5000/mcL) are not recommended to receive the faster infusion. More Information.

August 19, 2011 – The U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (ADCETRIS) for the treatment of patients systemic anaplastic large cell lymphoma after failure of at least one combination chemotherapy regimen. 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 antibody drug conjugate directed to CD30-expressing cells. More Information.