U.S. and European Regulators Accept Venetoclax for Chronic Lymphocytic Leukemia

AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted AbbVie's New Drug Application (NDA) granting priority review for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at least one prior therapy, including patients with 17p deletion. With priority review, the FDA's goals include a faster timeline for review of six months, compared to 10 months for the standard review period. Additionally, AbbVie announced the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for venetoclax for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion or TP53 mutation.

 

Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed in partnership with Genentech and Roche to treat CLL. Venetoclax is believed to lead some cells, including some cells with CLL, to undergo apoptosis, or cell death.

The FDA granted venetoclax Breakthrough Therapy Designation (BTD) in April 2015 for the treatment of CLL in previously treated patients with the 17p deletion genetic mutation, underscoring the potential for venetoclax to provide substantial improvement over current therapies in this difficult to treat patient population.

AbbVie released PHASE 1 Clinical Data of VENETOCLAX

AbbVie announced the online publication of new data in the New England Journal of Medicine (NEJM) showing some patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated with venetoclax experienced a response, including complete responses. The article reports data from Arm A of the study, in which all patients had relapsed CLL and more than one-third were refractory to their last treatment. Venetoclax is an investigational, first-in-class, B-cell lymphoma-2 (BCL-2) inhibitor being developed and commercialized by AbbVie and Genentech and Roche.

In arm A of the M12-175 study, venetoclax had an overall response rate of 79 percent (n=92/116) and complete response in 20 percent of patients. Serious adverse events (AEs) occurring in ≥ 2 percent of patients were febrile neutropenia, pneumonia, immune thrombocytopenia, tumor lysis syndrome, diarrhea, fluid overload, hyperglycemia, prostate cancer, pyrexia, upper respiratory tract infection, and viral upper respiratory tract infection. Grade 3 or 4 AEs occurring in ≥ 2 percentof patients were diarrhea, nausea, neutropenia, fatigue, anemia, thrombocytopenia, vomiting and hyperglycemia.

CLL is a typically slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell.  Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent.

Venetoclax is an investigational oral BCL-2 inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be over expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.