LONDON, Mar 11 (APM) - Merck Sharp & Dohme's Keytruda (pembrolizumab) is the first drug to be approved in the UK via the new Early Access to Medicines scheme (EAMS), in advanced melanoma, the Department of Health announced on Wednesday.
“The treatment is considered a next generation drug in cancer care, stimulating the body’s immune system to fight the disease and is the first to have been made available under this scheme,” the DH said in a statement, without expanding upon the indication.
The UK is the latest country to fast-track patient access to MSD’s Keytruda in this indication. In September, the U.S. Food and Drug Administration said it had approved its use in unresectable or metastatic melanoma following positive Phase Ib results, under its Breakthrough Therapy designation and subsequent accelerated approval process. (APMMA 39601) (APMMA 39089)
In France, it has been approved for early access in the off-label setting for patients with BRAF mutation who have failed to respond to BRAF inhibitor and who are naïve to BMS's Yervoy (ipilimumab), in the treatment of patients aged over 18 presenting a stage III/IV melanoma. (APMMA 41325)
The UK’s scheme was launched in March 2014, and brought in a two-step process allowing companies the opportunity to seek early access if their novel therapy provided treatment in unmet need for seriously ill patients. (APMMA 37638)
The first step, if approved under strict criteria, gives companies including small biotechs a ‘promising innovation’ (PIM) award. Only drugs with this status can go on to be filed for the subsequent EAMS.
The UK announcement will mean BMS’s Keytruda “will be commissioned by NHS England through its specialised commissioning arrangements, delivering a single national approach to commissioning,” the DH statement said.
The announcement was made among several other ‘good news’ items in the DH statement, including the use of DNA sequencing in the National Health Service to diagnose patients with rare diseases and personalise their therapies, and developments in the field of precision proton beam radiotherapy for certain cancer patients.
The DH also announced the launch of an ‘innovative medicines and medical technology review’, to assess how innovations are regulated and reimbursed and adopted in the NHS.
The review will be supported by the Wellcome Trust and led by Sir Hugh Taylor, chairman of Guy’s and St Thomas’ NHS Foundation Trust, London, and will report back later this year.
The DH’s list of achievements is published at a highly sensitive time politically, with the country’s general election taking place in two months. It also follows news last week that despite multi-million pounds of government funding into the life sciences sector, UK revenues in the industry are falling, in part explained by patent losses. (APMMA 41751)
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