UK: Merck’s Keytruda Gets 1st Ever Early Access
Merck’s advanced melanoma drug, Pembrolizumab (marketed in the US as Keytruda), is the first drug to be approved through the UK’s new Early Access to Medicines Scheme (EAMS). Keytruda is considered a next generation drug in oncology care that stimulates the body’s immune system to fight the cancer.
In 2014, the UK government introduces EAMS to help patients gain access to promising and new treatments before the European license is granted. When there is a clear unmet medical need, EAMS’ goal is to give patients with serious debilitating or life-threatening conditions, access to medicines that don’t yet have marketing authorizations. Under the scheme, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission is made. The opinion lasts for a year and can be renewed. The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines. For additional information on EAMS please reference the MHRA website. The European Marketing Authorization for Pembrolizumab for advanced melanoma is currently under review.
According to the March 10th Merck Press Release, more than 3,500 people in over 40 countries have received early access to Pembrolizumab for advanced melanoma through Merck’s global expanded access program.
In the US, Keytruda:
• Receives FDA Orphan Drug Designation (ODD) in November 2012
• Receives FDA Breakthrough Therapy Designation (BTD) in April 2013
• Receives FDA approval in September 2014.
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