Mantle Cell Lymphoma: FDA Drug Updates

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 10, 2014 - The U.S. Food and Drug Administration (FDA) approved bortezomib (Velcade) for previously untreated patients with mantle cell lymphoma. More information.

November 13, 2013 - The U.S. Food and Drug Administration (FDA) granted accelerated approval to Ibrutinib (Imbruvica) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. More Information

June 5, 2013 - The U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies. Lenalidomide currently represents the first and only oral therapy for mantle cell lymphoma, which is a rare, B-cell non-Hodgkin lymphoma. Mantle cell lymphoma comprises about five percent of all non-Hodgkin lymphomas and is usually diagnosed as a late-stage disease that has typically spread to the gastrointestinal tract and bone marrow.  More information.

October 19, 2012 - The U.S. Food and Drug Administration (FDA) approved a 90-minute infusion for rituximab (Rituxan) 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.

January 23, 2012 - The U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for bortezomib (Velcade), which updates the existing label to include the subcutaneous method of administration for the treatment of mantle cell lymphoma (MCL) patients who have received at least one prior therapy. More Information