Venclexta (venetoclax) is a therapy developed by Genentech in partnership with AbbVie and the Leukemia & Lymphoma Society (LLS). It is approved by the U.S. Food and Drug Administration (FDA) to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), two very similar types of leukemia. Venclexta also is approved in combination with azacitidine, decitabine, or cytarabine to treat patients with newly diagnosed acute myeloid leukemia (AML).
How does Venclexta work?
Normally, cells that become damaged or non-functional go through a process called apoptosis, or programmed cell death. In cancer, these apoptotic pathways often are bypassed because many cancer cells produce large quantities of pro-survival proteins that block the process. One such pro-survival protein is BCL-2. It binds to pro-apoptotic proteins, preventing their function and allowing cells to survive even when they should not.
Venclexta contains a small molecule that binds specifically to BCL-2, displacing the pro-apoptotic proteins that are bound to it. Once released, the pro-apoptotic proteins activate apoptosis signaling cascades, causing the cells to self-destruct.
Venclexta in clinical trials
A Phase 1 clinical trial (NCT01328626) tested the safety, tolerability, and efficacy of Venclexta in people with CLL or SLL. In its first phase, participants were treated with increasing doses of the therapy. Once a dosage was established for each group of patients, all groups received the treatment at that dosage.
The results of the study were published in the New England Journal of Medicine. In the study’s first half, three patients out of 56 developed tumor lysis syndrome, a serious condition caused by the rapid death of cancer cells. In that complication, the cancer cells die releasing their cellular contents faster than the body can process or remove them.
In the trial’s expansion phase, none of the participants developed tumor lysis syndrome. Among 116 individuals who received Venclexta, 92 responded to treatment. Complete remission occurred in 20% of patients. The safety profile of the treatment was considered acceptable; the most common side effects were diarrhea, nausea, upper respiratory tract infection, and low white blood cell counts.
There are many other clinical trials currently testing the effects of Venclexta on its own or in combination with other medications for the treatment of lymphoma worldwide. More information about these trials can be found on clinicaltrials.gov.
Venclexta can cause side effects such as low white blood cell counts and risk of serious infection.
The metabolism of Venclexta (how quickly the body clears the medication) will be changed if the patient eats grapefruit, Seville oranges, or starfruit, so these foods should be avoided when taking this medication.
Last updated: Feb. 10, 2020
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