AbbVie's Venclyxto approved in Europe in CLL

AbbVie’s Venclyxto has been approved in Europe for patients with difficult-to-treat chronic lymphocytic leukaemia (CLL) – an oral drug which has been predicted to be a big seller in the future.

In a report on blockbusters poised to hit the market this year, Thomson Reuters forecasts sales of Venclyxto will be almost $1.5 billion by 2020, while others have said the figure may be as high as $2 billion.

The European Commission recommended Venclyxto (venetoclax) monotherapy as a monotherapy for CLL without a 17p deletion or TP53 mutation, in adults who cannot take or have failed both a chemoimmunotherapy or a B-cell receptor pathway inhibitor.

A first-in-class BCL-2 inhibitor co-developed with Roche’s Genentech unit, Venclyxto is also indicated in adults with these mutations who are either unsuitable for or have failed a BCR inhibitor.

CLL is usually a slow-progressing cancer but the cancers targeted by Venclyxto are much more aggressive.

One in two CLL patients failing current standards of care could face survival as short as three months.

In patients failing on B-cell receptor (BCR) inhibitors, 72% of patients taking venetoclax are yet to have their disease progress after 12 months. In patients with previously treated CLL and 17p deletion, median progression free survival is over 27 months.

The drug is also being tested in combination therapies earlier in CLL and for other blood cancers such as non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma and follicular lymphoma.

It will compete against two well-established drugs – Janssen and AbbVie’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib), although there are safety concerns about the latter following deaths in trials in other uses.

Patients on Zydelig should receive antibiotics during treatment and for two-to-six months after in Europe as a safety precaution – a ruling likely to hit sales.

Imbruvica is forecast to outshine venetoclax however, with Thompson Reuters predicting annual sales of more than $6.4 billion in 2020.

The BCL-2 protein prevents programmed cell death of some cells, including lymphocytes, and can be overexpressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein.

Venclyxto was approved in the US in April in second line CLL, where it is marketed as Venclexta.