The combination therapy of Yuhan Corp.'s Leclaza and Johnson & Johnson's Rybrevant has been approved for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.
Leclaza is the first Korean-developed cancer drug to receive FDA authorization.
The combination therapy demonstrated positive results in the Phase 3 Maripos clinical trial, reducing the risk of disease progression or death by 30 percent compared to Oxford-AstraZeneca's Tagrisso alone, which is the standard of care for EGFR-mutated lung cancer, according to the company.
The median progression-free survival was longer with the combination therapy, at 23.7 months compared to 16.6 months with Tagrisso.
In Korea, Leclaza was approved as a new drug by the Ministry of Food and Drug Safety in 2021 and as a first-line treatment for NSCLC in June last year.
"The approval of Leclaza by the FDA is a significant outcome of Yuhan's R&D investments through open innovation," said Wook Je-cho, president of Yuhan.
"This approval is not the final destination but a milestone that will serve as a foundation for Yuhan to become a global top 50 pharmaceutical company by launching innovative new drugs that represent Korea."
