Pembrolizumab, MSD’s (NJ, USA) humanized monoclonal antibody immunotherapy that targets the PD-1 receptor, has been approved in the UK for the treatment of advanced melanoma through the Early Access to Medicines Scheme (EAMS).
Introduced by the UK Government in 2014, EAMS aims to help patients access promising innovative medicines prior to marketing authorization. This week’s approval means pembrolizumab represents the first drug to be approved through the scheme.
With a 5-year survival rate of >20%, advanced melanoma represents a disease for which more treatment options are required. Following the EAMS approval, MSD expects that a ‘substantial number’ of individuals with advanced melanoma in the UK will benefit from this accelerated access.
Gillian Nuttall of the charity Melanoma UK reacted positively to the news of the approval, commenting: “At the moment, there are limited options for advanced melanoma patients, the majority of whom are in difficult positions, which simply means they cannot afford to play any kind of waiting game. We welcome early access to this treatment for advanced patients made possible through this new scheme. There is clearly an unmet need and we are delighted such progress is being made.”
Pembrolizumab works to unmask cancer cells from the immune system by blocking the interaction between the PD-1 receptor and its ligands, PD-L1 and PD-L2 – an interaction that cancers can harness to disguise themselves and prevent immune responses. By binding to the PD-1 receptor, pembrolizumab is able to overcome this PD-1 pathway-mediated inhibition of the antitumor response.
The agent is currently being studied in more than 30 different cancers in various studies, thought to including in total an estimated 8000 patients. Previous trials with the drug have demonstrated an improvement in the prognosis of patients with advanced melanoma, many of whom have shown a durable response to the therapy.
“Immunotherapy drugs when successful stimulate the immune system so it can attack melanoma. For years we have been trying to develop drugs that can achieve good results without serious side effects. My patients responding to pembrolizumab in general have experienced durable control of their disease with relatively few side-effects,” commented James Larkin, Medical Oncologist at The Royal Marsden (UK).
When asked how significant this approval might be for melanoma patients, Cancer Research UK’s head of policy Emma Greenwood told Oncology Central : “Pembrolizumab is another example of the great progress we’ve made in developing immune treatments for cancer, so it’s encouraging to see it being made available to patients earlier.”
Compared with other schemes such as the Cancer Drugs Fund that only consider licenced agents, Greenwood stated that EAMS is “…a step in the right direction in terms of patients getting access to new treatments faster. With this approach, relevant data will be collected and patients are closely monitored. We look forward to seeing whether it can be replicated with other promising drugs.”
Source: First treatment available through the new UK Early Access to Medicines Scheme is announced – MSD press release, 11th March 2015.