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UK regulator approves Bavencio▼ (avelumab) used in combination with Inlyta (axitinib) in treating kidney cancer

Bavencio▼, for Renal cell carcinoma and Kidney cancer from Merck Serono

The Medicines and Healthcare products Regulatory Agency (MHRA) have approved Merck-Pfizer's cancer treatment avelumab, brand name Bavencio▼, in combination with Pfizer's axitinib, brand name Inlyta, for first-line treatment of advanced renal (kidney) cancer. The treatment will be funded under the early access to medicines scheme (EAMS) and will be available for use by NHS England.

The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines to UK patients that have a high unmet clinical need.

The combination is not licensed in Europe for advanced renal cell cancer and is currently under review by European Medicines Agency.

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

Why has avelumab been given a positive Early Access to Medicine?
Renal cell carcinoma (RCC) is the most common form of kidney cancer. When it has spread, the survival rate at 5 years in the UK is around 56%. Despite the substantial improvements in the treatment of kidney cancer, long lasting and complete tumour shrinkage are uncommon. The combination of avelumab and axitinib has been shown to notably slow the progression of cancer compared to standard current treatment in patients with good predicted outcome as well as those with poor predicted outcome.

How avelumab works (source MHRA)
Avelumab is a type of protein, called a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Avelumab has been designed to attach to and block the activity of a protein called PD-L1, which is found on the surface of tumour and immune cells. By blocking PD-L1, avelumab restores the capacity of immune cells to fight cancer cells.

How axitinib works (source MHRA)
Axitinib blocks some enzymes known as tyrosine kinases that are found on the surface of cancer cells and works by reducing the blood supply to the tumour and slowing down the growth of cancer.

Bavencio was first made available in the EU in 2017. It is manufactured by Merck-Pfizer.
Inlyta was first made available in the EU in 2012. It is manufactured by Pfizer.

Sources
European Medicines Agency website page for Bavencio and Inlyta
MHRA website
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 04/08/19
Links available in External Resources

MHRA information on Bavencio and Inlyta

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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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