Venclyxto monotherapy is indicated for the treatment of Chronic Lymphocytic Leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

EMA

Class:

BCL-2 inhibitor

R/R

SmPChttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004106/WC500218800.pdf 

1. Approved Labelling 

Venclyxto monotherapy is indicated for the treatment of Chronic Lymphocytic Leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. 

2. Treatment Regimen 

Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

The starting dose is 20 mg of venetoclax once daily for 7 days. The dose must be gradually increased over a period of 5 weeks up to the recommended daily dose of 400 mg as shown in Table 1.

Table 1. Dosing increase schedule
Week Venclyxto daily dose
1 20 mg
2 50 mg
3 100 mg
4 200 mg
5 and beyond  400 mg

The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of Tumour Lysis Syndrome (TLS).

Treatment should be continued until disease progression or no longer tolerated by the patient.

3. AE/Warnings

Please see section 4.4 of the SmPC

 

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