english.prescrire.org > Spotlight > Archives : 2018 > Venetoclax (Venclyxto°): another drug made available on the market too soon

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Venetoclax (Venclyxto°): another drug made available on the market too soon

Ventoclax inhibits a protein often present in abnormal lymphocytes in cases of chronic lymphocytic leukaemia. But does venetoclax extend the patient’s life span? We don’t know because we don’t have a comparative trial.

Chronic lymphocytic leukaemia is characterised by a progressive accumulation of non-functional B lymphocytes. It generally affects people over the age of 60 and is the most common form of leukaemia in adults. The proportion of patients alive 10 years after diagnosis varies between 25% and 80% depending on age, stage of the disease, and the presence of certain genetic abnormalities in tumour cells.

Despite inadequate and inappropriate evaluation, drugs such as ibrutinib and idelalisib have been authorised with no evidence of their efficacy. In patients with chronic relapsed or refractory lymphocytic leukaemia, after the use of these drugs, ventoclax has been authorised in the European Union as a monotherapy on the basis of non-controlled trials with a follow-up of only a few months. It is not known whether or not it prolongs patients’ lives. Its known adverse effects are haematological, infectious and intestinal disorders and tumour lysis syndromes.

Venetoclax is an example of a cancer drug that has been put on the market even though poorly evaluated (and very expensive), while offering only minimal or dubious benefits. All too often, marketing authorisations are granted when the clinical evaluation does not make it possible to determine the drug’s benefit for patients. Moreover, these market developments place a heavy burden on welfare systems’ resources, to the detriment of other public-interest expenditure.

©Prescrire 1 November 2018

"Venetoclax (Venclyxto°) and chronic lymphocytic leukaemia. Premature marketing authorisation" Prescrire Int 2018; 27 (198): 259-260. (Pdf, subscribers only).

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Download the full review.
Pdf, subscribers only

See also:

Ibrutinib - Relapsed chronic
lymphocytic leukaemia
and mantle cell lymphoma:
uncertain impact on survival
Prescrire Int 2016;
25 (170): 89-92.  
Pdf, subscribers only

Idelalisib: deaths
from infections
Prescrire Int 2016;
25 (175): 243.
Pdf, subscribers only

Ofatumumab in previously
untreated chronic lymphocytic
leukaemia. No clear advantages
when added to chlorambucil
Prescrire Int 2015;
24 (165): 262-263.
Pdf, subscribers only