Sotorasib Approved in European Union, Japan for Adults with KRAS G12C-Mutated Advanced NSCLC
The European Commission (EC) and the Japan Ministry of Health, Labour and Welfare (MHLW) have granted approval for Lumykras®/Lumakras® (sotorasib), a first-in-class KRAS G12C inhibitor, for the treatment of adults with advanced NSCLC with KRAS G12C mutation, whose cancer has progressed after at least one prior line of systemic therapy.
The EC and MHLW approvals are based on the positive results from the Phase 2 CodeBreaK 100 clinical trial in NSCLC, the largest trial conducted to date for patients with the KRAS G12C mutation. In the trial, sotorasib 960 mg, administered orally once daily, demonstrated an objective response rate of 37.1% (95% CI: 28.6-46.2) and a median duration of response of 11.1 months.
Osimertinib Approved for Use in Scotland for Treatment of EGFR Mutated Advanced Lung Cancer
The Scottish Medicines Consortium (SMC) has accepted Tagrisso® (osimertinib), a 3rd generation EGFR inhibitor, for use within NHS Scotland as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.
Results from the FLAURA Phase III trial showed a statistically significant and clinically meaningful improvement in median overall survival in patients treated with osimertinib, versus gefitinib or erlotinib. Osimertinib also showed a statistically significant and clinically meaningful 52% reduction in the risk of central nervous system (CNS) disease progression at 18 months, increasing the time patients with CNS metastases lived without CNS disease progression or death.