(Health Korea News / Lee Si-woo) Yuhan Corporation’s non-small cell lung cancer (NSCLC) treatment ‘Leclaza’ (ingredient name: lazertinib) is expected to soon receive product approval in Europe following the US.
On the 15th local time, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approved Yuhan Corporation’s ‘Lecraza’ and Johnson & Johnson’s (J&J) ‘Rybrevant’ (ingredient name: amivantamab). A positive opinion was given regarding combination therapy.
CHMP recommended product approval for the combination therapy of ‘Lecraza’ and ‘Librivant’ as the first-line treatment for adult patients with locally advanced NSCLC with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. .
Although CHMP’s recommendations are not binding, the European Commission (EC) generally respects them. Therefore, the ‘Lecraza’ + ‘Librivant’ combination therapy is expected to receive final approval within 2 to 3 months after review by the EC. (See related article below)
Previously, the U.S. Food and Drug Administration (FDA) approved the marketing of the ‘Lecraza’ and ‘Librivant’ combination therapy in August this year. The FDA’s approval at the time was identical to CHMP’s current recommendation.
‘Lecraza’, approved as Korea’s 31st new drug in January 2021, is a third-generation tyrosine kinase inhibitor (TKI), and will be eligible for health insurance coverage six months after approval was expanded to domestic first-line treatment in June 2023. The prescription volume reached 20 billion won in the first quarter of 2024.
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Source: www.hkn24.com
