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Keytruda▼ - approved for use in Scotland for the treatment of stage III melanoma

Keytruda▼, for Melanoma from Merck Sharp and Dohme

The Scottish Medicines Consortium have approved the use of Merck Sharp and Dohme's cancer medicine pembrolizumab, brand name Keytruda▼, for use in treating stage III melanoma.

This means that Keytruda can be used and funded by NHS Scotland for use as a single therapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

Adjuvant therapy is applied after initial treatment for cancer, especially to suppress secondary tumour formation.

Resection is the process of cutting out tissue or part of an organ, in this case the melanoma.

Recurrence-free survival was significantly longer in the pembrolizumab group compared with placebo in a phase III study of adult patients with completely resected, stage III melanoma with lymph node involvement.


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

About melanoma (source NHS)
Melanoma is a type of skin cancer that can spread to other organs in the body.

The most common sign of melanoma is the appearance of a new mole or a change in an existing mole. This can occur anywhere on the body, but the most commonly affected areas are the back in men and the legs in women. Melanomas are uncommon in areas which are protected from sun exposure, such as the buttocks and the scalp.

In most cases, melanomas have an irregular shape and are more than one colour. The mole may also be larger than normal and can sometimes be itchy or bleed. Look out for a mole which changes progressively in shape, size and/or colour.

Stage 3 melanoma is characterised by:
  • Stage 3A – the melanoma has spread into 1 to 3 nearby lymph nodes, but they're not enlarged; the melanoma isn't ulcerated and hasn't spread further
  • Stage 3B – the melanoma is ulcerated and has spread into 1 to 3 nearby lymph nodes but they're not enlarged, or the melanoma isn't ulcerated and has spread into 1 to 3 nearby lymph nodes and they are enlarged, or the melanoma has spread to small areas of skin or lymphatic channels, but not to nearby lymph nodes
  • Stage 3C – the melanoma is ulcerated and has spread into 1 to 3 nearby lymph nodes and they're enlarged, or it's spread into 4 or more lymph nodes nearby

About Keytruda (source EMA)
Keytruda is a cancer medicine used to treat:
  • melanoma, a skin cancer
  • non-small cell lung cancer (NSCLC), a type of lung cancer
  • classical Hodgkin lymphoma, a cancer of the white blood cells
  • urothelial cancer, a cancer of the bladder and urinary tract
  • a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC)
Keytruda is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments. In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.

Keytruda is also used to help prevent the cancer from coming back after they had surgery to remove melanoma (adjuvant therapy).

Keytruda is used on its own except for non-squamous NSCLC where it is used in combination with pemetrexed and platinum chemotherapy.

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and block a receptor called PD-1. Some cancers can make a protein (PD-L1) that combines with PD-1 to switch off the activity of certain cells of the immune system (the body’s natural defences) preventing them from attacking the cancer. By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.

Keytruda was first made available in the EU in 2015. It is manufactured by Merck Sharp and Dohme.

Sources
European Medicines Agency website page for Keytruda
NHS website for melanoma
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 15/05/19
Links available in full article

SMC information on Keytruda in treating melanoma

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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