Leclaza (component name lazertinib, aka Lazcluze in the U.S.), an anti-cancer drug developed by Yuhan Corp., has received approval from the U.S. Food and Drug Administration as part of a first-line treatment with Johnson & Johnson's chemotherapy-free treatment Rybrevant (amivantamab). (Yuhan Corp.'s official website)

By Hong Angie

A lung cancer treatment developed by a domestic pharmaceutical company is the country's first anti-cancer drug to receive approval from the U.S. Food and Drug Administration (FDA).

The American pharmaceutical giant Johnson & Johnson on Aug. 20 said its dual cancer treatment of Rybrevant (amivantamab) and Leclaza (component name lazertinib, aka Lazcluze in the U.S.) developed by Korea's Yuhan Corp. received FDA approval as a first-line treatment for EGFR (epidermal growth factor receptor)-mutated advanced lung cancer.

The approval was based on the global Phase 3 clinical trial Mariposa, which found that when both drugs were used together, the risk of death from the disease fell 30% more than when other treatments were used. The progression-free survival period was also extended nine months.

This dual treatment is a first-line treatment for adults with advanced or metastatic non-small cell lung cancer with EGFR exo 19 deletions or exon 21 (L858R) substitution mutations.

Johnson & Johnson hailed the news by calling the treatment "the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib."

Yuhan Corp. CEO Cho Wook-je said, "We consider Leclaza's approval in the U.S. a milestone in our company's development and will focus on research and development to create the second and third Leclazas."

In January 2021, Leclaza was approved as the country's 31st new drug and as a first-line treatment in June last year. 

Yuhan Corp. CEO Cho Wook-je on Aug. 23 speaks at a news conference on the future of his company's business after U.S. approval of Leclaza at the hotel Conrad Seoul in Seoul's Yeongdeungpo-gu District. (Yonhap News)

shong9412@korea.kr