Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: FDA Updates

December 1, 2023 – the U.S. Food and Drug Administration (FDA) announced it has approved BTK inhibitor, pirtobrutinib (Jaypirca, Eli Lilly and Company), for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. More Information.

April 21, 2020 – The U.S. Food and Drug Administration (FDA) approved the use of ibrutinib (IMBRUVICA) in combination with rituximab (RITUXAN) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). More Information.

November 21, 2019 – The U.S. Food and Drug Administration (FDA) approved the use of acalabrutinib (CALQUENCE) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). More Information.

May 15, 2019 – The U.S. Food and Drug Administration (FDA) approved the use of venetoclax (VENCLEXTA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). More Information.

January 28, 2019 – The U.S. Food and Drug Administration (FDA) approved the use of ibrutinib (IMBRUVICA) in combination with obinutuzumab (GAZYVA) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). More Information.

September 24, 2018 – The U.S. Food and Drug Administration (FDA) approved duvelisib (COPIKTRA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. More Information.

June 8, 2018 – The U.S. Food and Drug Administration (FDA) approved venetoclax (VENCLEXTA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. More Information.

June 22, 2017 – The U.S. Food and Drug Administration (FDA) approved the combination of rituximab and hyaluronidase human (RITUXAN HYCELA) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC). More Information.

August 31, 2016 – The U.S. Food and Drug Administration (FDA) approved ofatumumab (ARZERRA) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.  More information. Read LRF’s official statment.

April 11, 2016 – The U.S. Food and Drug Administration (FDA) approved venetoclax (VENCLEXTA) for previously treated (relapsed/refractory) chronic lymphocytic leukemia (CLL) patients with the 17p deletion genetic mutation. Read LRF’s official statement.

FDA venetoclax drug label
FDA venetoclax press announcement
FDA venetoclax approval letter

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.

March 4, 2016 – The U.S. Food and Drug Administration (FDA) approved the use of ibrutinib (IMBRUVICA) for front-line use in the treatment of chronic lymphocytic leukemia (CLL), representing the first chemotherapy-free treatment option of its kind available to patients regardless of treatment history. More Information. Read LRF’s official statement here.

January 19, 2016 – The U.S. Food and Drug Administration approved ofatumumab (ARZERRA) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab. More Information.

December 7, 2015 – The U.S. Food and Drug Administration (FDA) has 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.

July 28, 2014 – The U.S. Food and Drug Administration (FDA) expanded the approved use of ibrutinib (IMBRUVICA) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Ibrutinib received a breakthrough therapy designation for this use. 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.

April 17, 2014 – The U.S. Food and Drug Administration (FDA) approved ofatumumab (ARZERRA) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. More Information.

February 12, 2014 – The U.S. Food and Drug Administration (FDA) granted accelerated approval to ibrutinib (IMBRUVICA) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. More Information.

November 1, 2013 – The U.S. Food and Drug Administration (FDA) approved obinutuzumab (GAZYVA) for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). 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.