In a landmark development for cancer treatment in Great Britain, Amgen's first-in-class KRAS inhibitor Lumykras (sotorasib) has secured MHRA approval, accompanied by an innovative early access agreement with the NHS. This breakthrough therapy targets previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
Breakthrough in "Undruggable" Target
The approval represents a significant milestone in cancer therapeutics, targeting the KRAS mutation that occurs in approximately 25% of NSCLC tumors, with the specific G12C mutation present in 13% of cases. These mutations are typically associated with more aggressive disease progression. Professor Charles Swanton, Cancer Research UK's chief clinician, emphasized the drug's significance: "Sotorasib is one of the most exciting breakthroughs in lung cancer in 20 years, expanding our list of effective precision therapies in lung cancer that are helping to improve survival for patients with limited options."
Clinical Efficacy and Patient Impact
The phase 2 CodeBreaK 100 trial, which supported the approval, demonstrated compelling results. The study showed that 37.1% of patients responded to Lumykras treatment, with an impressive 80.6% achieving disease control. Tumor growth was effectively halted for approximately seven months, offering new hope for patients with limited treatment options.
Implementation and Access
The NHS plans to initiate treatment access within weeks, potentially benefiting approximately 600 lung cancer patients in England. This rapid deployment is particularly significant given that lung cancer represents the third most common cancer in the UK, with Cancer Research UK estimating around 48,000 new cases annually.
Regulatory Innovation and Pricing
Lumykras marks a milestone as the first cancer medicine approved under Project Orbis, a global regulatory collaboration led by the FDA and including the MHRA, designed to accelerate patient access to innovative cancer treatments. In the United States, where the drug was approved in May under the brand name Lumakras, Amgen has set the price at $17,900 per month, aligning with other targeted cancer therapies.
Market Implications and Future Potential
Analysts project that Lumykras could achieve sales exceeding $1 billion, particularly if its use expands to first-line therapy and other KRAS-mutated cancers. While the drug is now available in England, Wales, and Scotland, patients in Northern Ireland must await European Commission approval due to post-Brexit regulatory frameworks.
The early access agreement for Lumykras has also sparked discussions about similar arrangements for other innovative cancer therapies. Breast Cancer NOW has called for Gilead Sciences to pursue a comparable access agreement for Trodelvy in triple-negative breast cancer treatment, highlighting the potential for this model to accelerate patient access to crucial new therapies.
