Introduction
Venetoclax (trade name EU: Venclyxto, U.S.: Venclexta) has been approved in Germany since December 2016 for use on its own in the treatment of chronic lymphocytic leukemia (CLL) in adults. Since October 2018 it has been an option for patients who have already had treatment, and is then used in combination with rituximab. As of March 2020, venetoclax has also been approved for use in patients who have not yet had any treatment, and is then used in combination with obinutuzumab.
CLL is a rare type of cancer. It typically arises when B cells of the immune system mutate and start multiplying uncontrollably in the blood, bone marrow and lymphatic system. CLL usually progresses slowly and doesn't cause any noticeable symptoms in the early stages. As the disease advances, infections, anemia, severe tiredness and exhaustion are common. Enlarged lymph nodes and an enlarged spleen are also typical signs.
In CLL, the body produces more of a certain protein called BCL-2. This allows more mutated B cells to survive. Venetoclax is used to inhibit BCL-2, stopping the disease from progressing.
Some patients also have specific genetic characteristics: A 17p deletion means that a gene isn't working properly. These patients can't have chemo-immunotherapy.
Venetoclax is an option for use on its own (monotherapy) in:
- people without a 17p deletion or TP53 mutation if chemo-immunotherapy and treatment with a B-cell receptor inhibitor (such as idelalisib or ibrutinib) wasn't successful, or
- people with a 17p deletion or TP53 mutation if treatment with a B-cell receptor inhibitor isn't an option or wasn't successful.
In people who have had at least one other treatment, venetoclax can be used in combination with rituximab.
In people who haven't had any treatment, venetoclax can be used in combination with obinutuzumab.
