Follicular Lymphoma: FDA Updates

May 27, 2022 – The U.S. Food and Drug Administration (FDA) announced it has approved the use of tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This is the third chimeric antigen receptor (CAR) T cell therapy approved for FL. More information.

March 5, 2021 – The U.S. Food and Drug Administration (FDA) announced it has approved the use of axicabtagene ciloeucel (YESCARTA, Kite, a Gilead Company) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This is the second chimeric antigen receptor (CAR) T cell therapy approved for FL. More information.

February 8, 2021 – The U.S. Food and Drug Administration (FDA) approved the use of the chimeric antigen receptor (CAR) T cell therapy lisocabtagene maraleucel (liso-cel, Breyanzi) for the treatment of adult patients with certain types of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Liso-cel, is the fourth CAR T cell therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL).

February 5, 2021 – The U.S. Food and Drug Administration (FDA) approved umbralisib (UKONIQ, TG Therapeutics), an oral kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen; and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. More Information.

June 18, 2020 – The U.S. Food and Drug Administration (FDA) approved tazemetostat (TAZVERIK), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by the EZH2 Mutation Test; and for adult patients with relapsed or refractory FL who have received at least 2 prior systemic therapies and have no satisfactory alternative treatment options. The EZH2 Mutation Test was also approved by the FDA on June 18, 2020 as a companion diagnostic for tazemetostat. More Information.

May 28, 2019 – The U.S. Food and Drug Administration (FDA) approved lenalidomide (REVLIMID) in combination with rituximab (RITUXAN) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL). More Information.

September 24, 2018 – The U.S. Food and Drug Administration (FDA) approved duvelisib (COPIKTRA) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior therapies. More Information.

November 16, 2017 – The U.S. Food and Drug Administration approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for the treatment of people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).  More Information.

September 14, 2017 – The U.S. Food and Drug Administration granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.  Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.  More Information.

June 22, 2017 – The U.S. Food and Drug Administration approved the subcutaneous combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with relapsed/refractory, previously untreated or non-progressing follicular lymphoma (FL). 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.

February 26, 2016 – The U.S. Food and Drug Administration (FDA) approved a new drug application for obinutuzumab (Gazyva) plus bendamustine for the treatment of some follicular lymphoma (FL) patients.  Obinutuzumab is now approved for FL patients who either did not respond to, or have relapsed after rituximab (Rituxan)-containing regimen. More Information.

December 7, 2015 – The U.S. Food and Drug Administration (FDA) approved a new drug application for bendamustine hydrochloride (Bendeka) for treatment of patients with chronic lymphocytic leukemia (CLL) and treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen. 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.

 July 23, 2014 – The U.S. Food and Drug Administration (FDA) approved idelalisib (Zydelig) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. FDA also granted accelerated approval to idelalisib for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. 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 28, 2011 – The U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan) as a maintenance therapy for patients with advanced follicular lymphoma who responded to initial treatment with rituximab plus chemotherapy (induction treatment). More information.