The FINANCIAL — Merck, known as MSD outside the United States and Canada, on October 9 announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a draft recommendation, in the form of a Final Appraisal Determination (FAD), recommending KEYTRUDA (pembrolizumab) as a first-line treatment option for adults with advanced melanoma.
“We are pleased that the U.K. government has recognized the value of KEYTRUDA, and thank the government for its efforts to ensure that patients in the U.K. who have advanced melanoma have access to KEYTRUDA as soon as possible,” said Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. “Merck has demonstrated our strong commitment to ensuring KEYTRUDA would be available as quickly as possible to patients in the U.K., and around the world. Since the first approval in the United States just more than a year ago, KEYTRUDA has been approved in 39 countries, including throughout the European Union.”
In addition to today’s NICE recommendation for KEYTRUDA as a first-line treatment option for adults with advanced melanoma, earlier this week NICE issued final guidance recommending KEYTRUDA for the treatment of advanced melanoma after disease progression with ipilimumab. KEYTRUDA was the first medicine available through the U.K. Early Access to Medicines Scheme (EAMS), which was introduced in the U.K. in 2014 to help patients with life-threatening or seriously debilitating conditions benefit from promising, innovative treatments before a European license has been granted, according to Merck.
“The availability of KEYTRUDA for first-line use in patients will be welcomed by the melanoma community,” said Gillian Nuttall, Founder of Melanoma UK. “Advanced melanoma is a very difficult disease to treat effectively and this treatment will give hope to many. We are delighted that patients will be able to access this treatment on the National Health Services and congratulate NICE on their swift decision making.”
Securing approvals for KEYTRUDA globally is a key element of Merck’s efforts to ensure that the medicine is broadly available for eligible patients with advanced melanoma who are in need of new options around the world. To date, KEYTRUDA has been approved for the treatment of certain patients with advanced melanoma by regulatory authorities in the United States and the EU, as well as Australia, Canada, Israel, Macau, New Zealand, Peru, South Korea, Switzerland, and the United Arab Emirates (UAE). Additionally, the U.S. Food and Drug Administration (FDA) recently approved KEYTRUDA for certain patients with advanced non-small cell lung cancer.