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Venclyxto▼ gets approval for use in Scotland

Venclyxto▼, for Chronic lymphocytic leukaemia from AbbVie

The Scottish Medicines Consortium (SMC) have approved AbbVie's medicine venetoclax, brand name Venclyxto▼, in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Progression-free survival was significantly longer in the venetoclax plus rituximab group compared with chemoimmunotherapy in a phase III study of patients with relapsed or refractory CLL.

This means that Venclyxto will be available as an option for patients being treated under the NHS in Scotland.

You can follow developments with Venclyxto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Venclyxto (source EMA)
Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).

Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.

It can also be used on its own in:
  • patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment). In these patients, Venclyxto is used when medicines known as B‑cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
  • patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B‑cell receptor pathway inhibitor have both failed.
The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2. This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines. By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows the progression of the disease.

Venclyxto was first made available in the EU in 2016. It is manufactured by AbbVie.

Sources
European Medicines Agency website page for Venclyxto
Accessed 13/08/19
Links available in External Resources

SMC information on Venclyxto

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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