Amgen’s Lumykras (sotorasib) has become the first active new technology to come through the Innovative Licensing and Access Pathway (ILAP – launched in January 2021 with the aim of delivering safe, early patient access to medicines by providing a mechanism for key regulatory bodies in the UK to work together and support the companies developing them) and receive a positive recommendation from the National Institute for Health and Care Excellence (NICE).
According to NICE, Lumykras is approved for use in the Cancer Drugs Fund (CDF) to enable “further direct comparative data, long-term evidence and information around cost effectiveness” to be collected and reassessed by the Institute in the future to determine whether it should be recommended for routine use in the national health service (NHS). The therapy, a once-a-day tablet, is approved for the treatment of patients with the KRAS G12C gene mutation of non-small-cell lung cancer who have progressed on, or are intolerant to, platinum-based chemotherapy and/or immunotherapy. According to NICE, over 500 people will be eligible to receive the treatment in 2022. Previously, there were no targeted treatment options for the KRAS G12C mutation and consequently patients had a poor prognosis.
Helen Knight, programme director in the Centre for Health Technology Evaluation at NICE comments, “We are determined to continue providing people with early access to innovative treatments, such as sotorasib, which has the potential to not only extend the lives of those with the KRAS G12C gene mutation of non-small-cell lung cancer but improve their quality of life”.
Notably, Lumykras was the second drug to receive marketing authorisation approval in the UK via Project Orbis (link to news story from 3 Feb 222 on Roche’s Tecentriq), an international partnership between medicines regulators in the UK, US, Australia, Brazil, Canada, Singapore, and Switzerland. The initiative is designed to speed up the approval process for promising cancer treatments. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Lumykras in September 2021, behind the US Food and Drug Administration (FDA) which approved the drug in May 2021 but ahead of the drug getting approval from the European Commission (EC) in January 2022.
- www.nice.org.uk, “Over 500 people a year can access a new life extending lung cancer treatment after NICE recommends its use within the Cancer Drugs Fund”, 3rd March 2022
- www.nice.org.uk, “Starting with the end in mind – the Innovative Licensing and Access Pathway”, 26th March 2021
- www.england.nhs.uk, “Hundreds of patients to benefit from revolutionary lung cancer drug on the NHS”, 3rd March 2022
- www.amgen.com, “EUROPEAN COMMISSION APPROVES LUMYKRAS® (SOTORASIB) FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER”, 9th January 2022
- www.amgen.com, “FDA Approves LUMAKRAS™ (Sotorasib), The First And Only Targeted Treatment For Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer”, 28th May 2021