SEOUL, Aug. 23 (Korea Bizwire) – In a significant breakthrough for South Korea’s pharmaceutical industry, Yuhan Corporation’s non-small cell lung cancer treatment has cleared a crucial hurdle with the U.S.
Food and Drug Administration (FDA). On August 20, the FDA approved the combination therapy of Yuhan’s Leclaza (lazertinib) and Johnson & Johnson’s targeted cancer drug Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations. This approval comes approximately six months after the FDA granted priority review status to the therapy in February.
The next steps will involve pricing negotiations and other procedures for the U.S. market launch.
Yuhan Corporation Central Research Institute (Image courtesy of Yuhan Corporation) According to multiple media reports, J&J projects that this combination therapy could generate over $5 billion in peak annual sales. Industry analysts anticipate a U.S.
launch within the year, as newly approved drugs typically reach the market within two to three months of authorization. Upon the drug’s launch, Yuhan is expected to receive a milestone payment of $60 million from J&J. This marks a significant return on Yuhan’s investment, which began in 2015 when it acquired the Leclaza candidate from the domestic biotech firm Oscotec.
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