Yuhan’s Lazertinib Gains European Approval, Marks Milestone for Korean Pharma

Another lung cancer drug, lazertinib developed by Yuhan Corporation, has now got marketing approval in Europe, not long after it received the green light in the United States under the brand name of Leclaza in Korean market and Lazcluze in the US. In addition, this dual approval puts lazertinib in the category of the first Korean-indigenously developed anticancer drug. Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, received the approval from the European Commission to use Rybrevant with Lazcluze for first-line treatment of adult patients with advanced NSCLC, harboring EGFR exon 19 deletions or exon 21 L858R substitution mutation.  

This strategy is underpinned by the phase 3 MARIPOSA trial showing the superiority of the combination therapy to osimertinib. The Rybrevant-Lazcluze regimen patients decreased progression or death risk by 30% and progressed-free survival time reached 23.7 months compared to the osemertinib of 16.6 months. Further, the therapy enhanced the duration of response to nine months higher than the other tested therapies. This is a landmark approval often underlining the importance of novel treatments in NSCLC, of which 85% of lung cancer cases in Europe and a considerable percentage of the total disease burden is constituted by the EGFR mutation-positive subtypes.  

The approval also triggers a $30 million: milestone payment for Yuhan from Janssen under the license and development agreement signed in 2018 for up to $1.255 billion. Nonetheless, according to the terms, Janssen continues to solely own all the rights to the development, manufacture and marketing of lazertinib within the global markets and Yuhan obtains headway payments plus royalties in the future. Lazertinib proves Korea’s pharma industry is gradually developing and gives new hope to the lung cancer patients across the globe.