EU & NICE authorise MSD's Keytruda for stage III melanoma

MSD’s Keytruda has been given a green light for use within the EU as an adjuvant treatment for stage III melanoma, and has also been made available on the NHS.

The National Institute for Health and Care Excellence (NICE) has recommended the drug’s use within the cancer drugs fund as monotherapy for the adjuvant treatment of adults with stage III melanoma with lymph node involvement who have undergone complete resection.

Melanoma patients are currently only monitored to see if their cancer returns, known as the "watch and wait" approach, at which point the cancer has often already progressed, so this approval is a fantastic milestone towards more appropriate treatment.

Both the EU and NICE approvals are based on data from the EORTC1325/KEYNOTE-054 trial, which found that Keytruda (pembrolizumab) was associated with significantly longer recurrence-free survival than those without the treatment.

"Pembrolizumab for the treatment of surgically removed stage III melanoma has the potential to prevent recurrence of the disease, according to results from the Keynote-054 study," said Dr Sophie Papa, senior lecturer and honorary consultant medical oncologist, King's College London and Guy's and St Thomas'.

"The decision by NICE to introduce pembrolizumab to our clinical options for this patient population through the cancer drugs fund (CDF) is a fantastic step forward.

"The focus on collecting NHS relevant clinical data through the CDF helps us access treatment now for patients. It also ensures that we continue to properly define the impact of this adjuvant treatment on preventing relapse of disease and, crucially, death from melanoma going forward."

Gillian Nuttall of Melanoma UK, noted: "The number of people with melanoma in the UK is continuing to rise, especially in younger people. The current ‘watch and wait’ approach after surgery can be a tense time for patients and their families, making this announcement even more important as we can begin to shift away from this. This is encouraging news for the patient population."

Keytruda was initially authorised in Europe for the treatment of both first-line and previously-treated adults with advanced melanoma in 2015.

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