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Unlicensed medicines

Skin cancer drug fast tracked under early access to medicines scheme

Pembrolizumab, a drug for advanced skin cancer, has become the first medicine to be fast tracked to patients under the UK’s early access to medicines scheme.

The scheme is designed to allow access to innovative drugs without clinicians having to wait for them to go through the lengthy licensing process.

Pembrolizumab can be used to treat advanced melanoma that has either spread to other organs or cannot be operated on. The drug will be provided to patients whose disease has progressed despite treatment with ipilimumab and, where appropriate, a V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor.

Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) gives a “scientific opinion” of the benefits and risks of the drug. For pembrolizumab, the MHRA examined data from a study of 173 patients with advanced melanoma for whom previous therapies failed. Treatment with pembrolizumab resulted in 21% of patients having a reduction in the size of their tumour, and for 47% of patients progression of their disease was halted for a substantial period of time. Around 60% of patients survived for at least one year.

Responsibility for use of pembrolizumab will rest with the prescriber, using the information from the MHRA. A risk management plan has also been implemented and healthcare professionals will be expected to report any adverse effects of the medicine.

Pembrolizumab is one of a new generation of drugs called immune checkpoint inhibitors.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068105

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