The European Commission (EC) has granted conditional marketing approval for Amgen’s Lumykras/Lumakras (sotorasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation who have progressed beyond one prior line of therapy.
Amgen made the announcement today, with the EC’s decision following a recommendation for approval issued by the Committee for Medicinal Products for Human USE (CHMP) based on positive results provided by the phase 2 CodeBreaK 100 NSCLC clinical trial.
The CodeBreaK clinical development programme for the drug sotorasib is designed to study NSCLC patients with an advanced solid tumour with the KRAS G12C mutation, in order to address the lack of medical provision for these cancers.
To date, the trial is the largest conducted for patients diagnosed with the KRAS G12C mutation. Accounting for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide, KRAS G12C is one of the most common driver mutations in NSCLC. Around 13-15% of European patients carrying the non-squamous NSCLC have the mutation.
Administered as a once-daily oral formulation, Lumykras (sotorasib) demonstrated a positive benefit-risk profile with deep and durable anticancer activity for patients diagnosed with locally advanced or metastatic NSCLC with the KRAS G12C mutation.
A subsequent benefit from the EC’s approval – contingent on local reimbursement applications – is that clinicians in all EU member countries, along with Iceland, Norway and Lichtenstein, will be able to make Lumykras available to eligible patients with NSCLC.
Future approvals following the EC’s decision may be conditional upon verification and description of clinical benefits in confirmatory trials.
In May 2021, the US Food and Drug Administration (FDA) granted Lumakras accelerated approval, making Amgen’s drug the first of its kind as a KRAS G12C inhibitor to receive regulatory approval.
David Reese, Amgen’s executive vice president of research and development, said: “The approval of Lumykras, the first and only targeted therapy for KRAS G12C-mutated NSCLC with proven efficacy, has the potential to transform treatment outcomes for people in the European Union living with this notoriously difficult-to-treat cancer.”
Reese added: “Amgen’s landmark scientific discovery allowed investigators to advance the first KRAS G12C inhibitor into the clinic, and we look forward to bringing this critical innovation to more patients across the globe.”