Tumor

US-based drugmaker Merck’s anti-programmed death receptor-1 (anti-PD-1) therapy pembrolizumab has been approved under the UK’s new Early Access to Medicines Scheme (EAMS) to treat advanced melanoma.

Marketed as Keytruda in the US, pembrolizumab is the first medicine to be accepted under the new EAMS scheme that was introduced by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2014.

Pembrolizumab is a humanised monoclonal antibody, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

It releases the PD-1 pathway-mediated inhibition of the immune response including the anti-tumour immune response, by binding to the PD-1 receptor and blocking the interaction with the receptor ligands.

Merck Research Laboratories president Dr Roger Perlmutter said: "Merck has charted a path to accelerate the development of pembrolizumab, and is collaborating with governments around the world to bring our anti-PD-1 therapy to cancer patients.

"This acceptance of pembrolizumab into the scheme will enable many patients in the UK with advanced melanoma to gain earlier access to pembrolizumab."

"This acceptance of pembrolizumab into the scheme will enable many patients in the UK with advanced melanoma to gain earlier access to pembrolizumab, and underscores the importance of creating new mechanisms to bring promising medicines to patients for whom there are limited options."

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The approval was based on review of data for pembrolizumab from KEYNOTE-001, a Phase Ib study of an anti-PD-1 therapy in patients with advanced melanoma.

Pembrolizumab obtained the promising innovative medicine (PIM) designation in the UK in October 2014, and is currently under review by the European Marketing Authorisation to treat advanced melanoma.

The US Food and Drug Administration previously granted breakthrough therapy designation for pembrolizumab to treat advanced melanoma when approved in September 2014.


Image: Histopathologic image of malignant melanoma. Photo: courtesy of KGH.