VENCLYXTO (venetoclax), BCL-2 inhibitor

High clinical benefit but no proven clinical added value for the therapeutic strategy only for the treatment of CLL:

- in the presence of 17p deletion or TP53 mutation for adults for whom B-cell antigen receptor inhibitor therapy has failed (second-line and subsequent treatments);

- in the absence of 17p deletion or TP53 mutation for adults for whom both chemoimmunotherapy and B-cell antigen receptor inhibitor therapy have failed (third-line and subsequent treatments)

Insufficient clinical benefit to justify reimbursement by public funding for the treatment of CLL in the presence of 17p deletion or TP53 mutation for adults ineligible for B-cell antigen receptor inhibitor therapy (first-line treatment).

• VENCLYXTO has been granted a marketing authorisation for monotherapy treatment of chronic lymphocytic leukaemia (CLL):

- in the presence of 17p deletion or TP53 mutation for adults ineligible for B-cell antigen receptor inhibitor therapy or for whom this therapy has failed.

- in the absence of 17p deletion or TP53 mutation for adults for whom both chemoimmunotherapy and B-cell antigen receptor inhibitor therapy have failed.

• In CLL patients, not carrying the 17p deletion or TP53 mutation, for whom both chemo-immunotherapy and B-cell antigen receptor inhibitor therapy had failed, a non-comparative study demonstrated high overall response rates, with no robust data in respect of clinically relevant criteria (survival) in exchange for toxicity, particularly haematological, and a risk of tumour lysis syndrome on commencement of treatment resulting in patient hospitalisation,
• In CLL patients in the presence of 17p deletion or TP53 mutation for whom B-cell antigen receptor inhibitor therapy had failed, a non-comparative study demonstrated high overall response rates, with no robust data in respect of clinically relevant criteria (survival) in exchange for toxicity, particularly haematological, and a risk of tumour lysis syndrome on commencement of treatment resulting in patient hospitalisation,
• In CLL patients in the presence of 17p deletion or TP53 mutation ineligible for B-cell antigen receptor inhibitor therapy, sufficient data are not available to document the benefit and clinical added value of this medicinal product (n=5 patients).

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