Getting a chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) diagnosis can be frightening and patients are naturally concerned about what their future may hold. Often, patients will ask their physician about their outlook, or prognosis, the medical term used to describe how the disease will progress and the likelihood of recovery. To be an educated healthcare consumer, it is important to understand the nature of CLL/SLL and what to expect from treatments, including any possible effects on quality of life, such as lifestyle, emotions and financial issues.
FDA approved a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva injection, for intravenous use, Genentech, Inc.) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL). December 24, 2014
Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) 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. Imbruvica received a breakthrough therapy designation for this use. More Information. July 28, 2014
FDA approved idelalisib (Zydelig tablets, GileadSciences, Inc.) 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. July 23, 2014
FDA approved ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) 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. April 17, 2014
FDA granted accelerated approval to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. More Information. February 12, 2014
FDA approved obinutuzumab (GAZYVA injection, for intravenous use, Genentech, Inc.; previously known as GA101) for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). More Information. November 1, 2013
FDA approved a 90-minute infusion for rituximab (Rituxan Injection, Genentech, Inc.) 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. October 19, 2012