VENCLEXTA® is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.1
VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is being studied in several other hematologic malignancies including acute myeloid leukemia (AML), multiple myeloma (MM), non-Hodgkin lymphoma (NHL) and myelodysplastic syndrome (MDS).9,10,11,12,13
In April 2016, the U.S. FDA first granted accelerated approval of VENCLEXTA for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.14 The FDA approved this indication under accelerated approval based on overall response rate.14 Based on the results of the MURANO study, VENCLEXTA was approved in June 2018 for the treatment of patients with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy.1 In November 2018, VENCLEXTA was approved in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy.15
Venetoclax is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.
B-cell Chronic Lymphocytic Leukemia (CLL) is a type of slow-growing leukemia that typically affects older adults. It originates in the bone marrow but mostly manifests in the blood and lymph nodes, involving mature-looking but functionally deficient lymphocytes (a type of white blood cell). CLL is characterized by a gradual increase in white blood cells, and it can often be detected through blood tests before symptoms become apparent. Symptoms might include swollen lymph nodes, fatigue, and increased susceptibility to infections. Treatment varies from monitoring without immediate intervention to more aggressive regimens based on the stage and progression of the disease.
Companion diagnostic testing plays a critical role in the decision to treat B-cell Chronic Lymphocytic Leukemia (CLL) with VENCLEXTA (venetoclax). Specifically, testing is used to identify patients with a 17p deletion, a genetic abnormality that is associated with a more aggressive form of CLL. Patients with this deletion are often less responsive to standard chemo-immunotherapy, making them good candidates for VENCLEXTA, which is specifically approved for this subset of patients. This targeted approach ensures that treatment is both effective and tailored to the genetic profile of the leukemia.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
VENCLEXTA (venetoclax) is a medication designed to selectively inhibit the BCL-2 protein, which supports cancer cell survival. It is used primarily for the treatment of CLL, especially in patients who have specific genetic markers linked to a more aggressive form of the disease.
VENCLEXTA is recommended for CLL patients who have a 17p deletion—a genetic alteration associated with a poor response to conventional chemotherapy.
VENCLEXTA targets and inhibits the BCL-2 protein, a molecule that helps cancer cells survive longer than normal. By blocking BCL-2, VENCLEXTA helps to trigger cancer cell death and reduce the number of malignant cells.
Patients may experience side effects such as low white blood cell counts, diarrhea, nausea, anemia, upper respiratory tract infection, and fatigue. It’s important to manage these side effects under the guidance of a healthcare provider.
VENCLEXTA is taken orally, with the dosage and length of treatment varying based on individual patient needs and specific treatment protocols, including combinations with other therapies.
Before starting VENCLEXTA, patients must undergo diagnostic testing to identify the presence of the 17p deletion or TP53 mutation, ensuring the treatment is appropriate and likely to be effective for their specific type of CLL.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.