[Yuhan Corp. Press Release] The U.S. Food and Drug Administration (FDA) has approved Yuhan Corporation’s LECLAZA (approved by FDA as LAZCLUZE)plus Johnson & Johnson’s RYBREVANT(amivantamab-vmjw) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Designated as a priority review by the FDA in February, the approval is based on positive results from the Phase 3 MARIPOSA study, which showed RYBREVANT plus LECLAZA reduced the risk of disease progression or death by 30 percent compared to osimertinib (median progression-free survival [PFS]: 23.7 months vs. 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The median duration of response (DOR) was nine months longer with RYBREVANT plus LECLAZA vs. osimertinib (25.8 months vs. 16.8 months), a secondary endpoint of the study.

With this approval, the combination of LECLAZA and RYBREVANT is the first and only multi-targeted, chemotherapy-free combination regimen with demonstrated superior progression-free survival over osimertinib as a first-line treatment for patients with EGFR-mutant NSCLC. LECLAZA, a highly selective, brain-penetrant, third-generation oral EGFR tyrosine kinase inhibitor (TKI), combined with RYBREVANT, an EGFR and MET receptor-directed bispecific antibody with immune cell-directing activity, delivers the only multi-targeted combination with mechanisms of action in both the extra-and intracellular domains of EGFR.

With this FDA approval, Yuhan Corporation has achieved the first success of open innovation in its R&D investments. LECLAZA, a non-small cell lung cancer treatment approved as the 31st domestically developed new drug in January 2021, received approval as a first-line treatment in Korea in June 2023 and obtained health insurance coverage within six months.

Starting from January 2024, LECLAZA, which became eligible for domestic health insurance coverage, achieved approximately 20 billion KRW in prescriptions in the first quarter, and is expected to reach the goal of 100 billion KRW within the year.

"The FDA's approval of LECLAZAis particularly significant as it marks the first major success of R&D investment through open innovation. We hope this approval serves not as an endpoint but as a milestone, laying the foundation for Yuhan to achieve its goal of becoming a Global Top 50 company," said Wook-Je Cho, CEO of Yuhan Corporation.