Yuhan Corporation's Non-Small Cell Lung Cancer Treatment 'Reclaza' Covered by Insurance Starting from the 1st
[Asia Economy Reporter Jihee Kim] Yuhan Corporation announced that from the 1st, health insurance coverage will be applied to the non-small cell lung cancer treatment drug 'Reclaza'. The target patients are those with epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small cell lung cancer.
Reclaza is an oral third-generation tyrosine kinase inhibitor (TKI) with high selectivity for the EGFR T790M resistance mutation. In particular, it can cross the blood-brain barrier (BBB), showing excellent efficacy and tolerability even in lung cancer patients with brain metastases.
According to domestic and international guidelines, administration of first to third-generation EGFR TKIs is recommended as first-line therapy for EGFR mutation-positive advanced or metastatic non-small cell lung cancer. However, a limitation is that many patients treated with first- and second-generation EGFR TKIs inevitably develop resistance, leading to disease progression. Among these resistance mechanisms, resistance due to the T790M mutation occurs in approximately 50-60% of cases.
This insurance coverage application was based on clinical trial data targeting patients with EGFR mutation-positive advanced non-small cell lung cancer. In 162 patients positive for the T790M mutation across all dosage groups, the objective response rates were 59% and 68%, and the median progression-free survival periods were 10.9 months and 11.0 months, respectively. Among patients assigned to the 240 mg dosage group (78 patients), the objective response rates for T790M mutation-positive patients (76 patients) were 58% and 72%, and the median progression-free survival periods were 11.0 months and 13.2 months, respectively.
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Jookje Cho, CEO of Yuhan Corporation, said, “We are pleased to provide a new treatment option for non-small cell lung cancer patients through the insurance coverage of Reclaza. We will strive to bring hope to lung cancer patients worldwide through ongoing global clinical trials such as ‘LASER301’ (a multinational phase 3 first-line treatment study) and combination clinical trials with ‘Amivantamab’ conducted by Janssen.”
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