Traslational Cancer Drugs Pharma SL

Eli Lilly’s Verzenios (abemaciclib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment for early-stage breast cancer in combination with endocrine therapy. The recommendation is specifically for adult patients with hormone receptor-positive, HER2-negative, node-positive early-stage breast cancer whose disease is at high risk of recurrence. It was based on results from the phase 3 randomised global monarchE trial, which met its primary endpoint. The trial showed that adjuvant treatment using Verzenios in combination with endocrine therapy decreased the risk of breast cancer recurrence by 32%. The NICE approval of Verzenios in combination with endocrine therapy makes it the first cyclin-dependent kinase (CDK) 4/6 inhibitor to be made available within NHS England for people with HR+, HER2-, node-positive early-stage breast cancer at high-risk of recurrence. The availability of the combination treatment on the NHS is supported by interim funding from the Cancer Drugs Fund until routine NHS baseline funding is established. The recommendation comes four weeks after a UK marketing authorisation was issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Professor Stephen Johnston, consultant medical oncologist and head of the breast unit at the Royal Marsden NHS Foundation Trust, Professor of breast cancer medicine at the Institute of Cancer Research, London and lead global principal investigator for the monarchE trial, said: “It’s a privilege to see the compelling results from the monarchE trial, which was a huge international effort, translate into a new treatment option for HR+ and HER2- breast cancer patients who have a high risk of their cancer recurring. “Despite previously receiving the very best standard of care treatment, this high risk node-positive group represents about 5,000 breast cancer patients each year who are at a much higher risk of their disease returning.” Johnston added that “abemaciclib is a significant breakthrough and is the first new treatment for this patient group in 20 years”. Breast cancer is the most common cancer among women globally, and despite the prognosis for HR+, HER2- early-stage breast cancer being generally good, 20-30% of patients could progress to incurable metastatic disease.

NHS England has unveiled its new Innovative Medicines Fund (IMF), to ensure patients have early access to ‘potentially life-saving’ new treatments. The IMF will be used to fast-track promising new drugs to the patients who need them, building upon the reformed Cancer Drugs Fund (CDF). The new fund, however, will support patients with any condition, including those with rare and genetic diseases. Through the IMF, these patients will gain early access to the most clinically promising treatments when further data is needed to support the National Institute for Health and Care Excellence’s (NICE) final recommendations. It will operate in the same way as the CDF, giving NICE another option aside from making an immediate decision about routine availability on the NHS for new drugs. “In the last year NHS England has successfully negotiated deals for a range of new treatments, including drugs which may allow toddlers with spinal muscular atrophy the chance to walk thanks to the ‘world’s most expensive drug’, as well as giving cystic fibrosis patients the latest medicines against their debilitating disease. This new fund will build on these successes, offering hope to even more patients,” said Simon Stevens, chief executive of the NHS. In a statement, NHS England said the new initiative will have £340m in funding, alongside the existing £340m CDF, meaning a total of £640m of ringfenced funding will be available to enable fast access to innovative drugs. In response to the new IMF, the ABPI’s chief executive Richard Torbett commented: “This commitment from the government is another important step towards improving access to new medicines for NHS patients.” “The fund can build on the success of the Cancer Drugs Fund and provide an opportunity for all patients to benefit early from the most promising treatments – including those for the rarest conditions. It also sends a signal to the global pharmaceutical industry that the UK is serious about using new health technologies, which in turn could help drive investment into UK life sciences,” he added.