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FDA Expands Venclexta Approval for Broader Treatment of CLL and SLL

The U.S. Food and Drug Administration (FDA) has recently expanded the approval for Venclexta® (venetoclax). Venclexta is now approved to treat chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with or without the chromosomal abnormality 17p deletion in people who have tried at least one prior therapy. This approval was done under priority review, a distinction the FDA uses to fast-track the drug review process for products that provide significant improvement in the treatment of serious conditions.1,2

Previously, Venclexta was only approved for use in people with CLL who had the 17p deletion.

Recent research on venetoclax

The expanded approval was based on data from a trial called MURANO. The study included 389 patients with CLL who had previously had at least one type of therapy. The participants were randomly assigned to receive either venetoclax with rituximab (VEN+R) or bendamustine with rituximab (B+R). The efficacy of each treatment arm was measured by progression-free survival. The overall response in the VEN+R group was 92%, compared with a 72% response rate in the B+R group. The combination of venetoclax and rituximab reduced the risk of disease progression or death by 81% compared to B+R therapy.1,3

How venetoclax works

Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that is found in large numbers on certain cancer cells and is involved in the cancer cell’s survival and resistance to chemotherapy. Venetoclax binds directly to this protein, weakening and killing cancer cells.4

Possible side effects of venetoclax

The most common side effects (greater than or equal to 20%) experienced by patients receiving venetoclax with rituximab were low white blood cell counts, diarrhea, upper respiratory tract infection, fatigue, cough and nausea. Venetoclax may cause fertility problems in men. Prior to starting treatment with venetoclax, patients should discuss their fertility options with their doctor.3,4

Important things to know about venetoclax

Venetoclax may cause tumor lysis syndrome (TLS), which occurs when large numbers of cancer cells die and release substances into the blood stream. TLS can cause kidney failure and may require the use of dialysis treatment. Doctors will monitor for TLS with blood tests and will minimize the risk by using intravenous (IV) fluids for hydration. Patients receiving venetoclax should tell their doctor if they have any signs of TLS, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.4

During treatment with venetoclax, patients will be monitored to check their blood cell levels and to check for signs of infection.4

People receiving venetoclax should not receive live vaccines.4

Venetoclax may be harmful to an unborn baby if taken during pregnancy. Women should use contraception while taking venetoclax.4

  1. FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy. U.S. Food & Drug Administration. Available at Accessed 6/11/18.
  2. Priority review. U.S. Food & Drug Administration. Available at Accessed 6/11/18.
  3. AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy (press release). Available at Accessed 6/11/18.
  4. Venclexta prescribing information. Available at Accessed 6/11/18.