First drug is approved under scheme that gives patients access to unlicensed medicines

BMJ 2015; 350 doi: (Published 13 March 2015) Cite this as: BMJ 2015;350:h1391
  1. Nigel Hawkes
  1. 1London

The first drug to be made available to patients in the United Kingdom before it is formally licensed will be pembrolizumab, a treatment for advanced melanoma.

Its use is made possible by the Early Access to Medicines Scheme (EAMS), in which medicines that have yet to complete their trials and gain a licence can be provided so long as they show a good balance of risk and benefit and where there is a clear unmet need. The scheme was developed with government support by the Medicines and Healthcare Products Regulatory Agency in response to criticism that patients in the UK often have to wait too long for new treatments to be made available.

Pembrolizumab, a monoclonal antibody, will be made available free of charge under the scheme by its manufacturer, MSD. The designation of the drug under EAMS lasts for a year but can …

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