Fierce Pharma August 23, 2024
Yuhan’s Lazcluze, licensed by Johnson & Johnson, has made history as the first Korea-developed novel cancer drug to be approved by the FDA. Merck has optioned in on one Kelun Biotech antibody-drug conjugate but returned another. A few U.S. lawmakers have asked the FDA to examine clinical trials involving sites at Chinese military hospitals. And more.
The FDA has approved Johnson & Johnson’s Rybrevant and Lazcluze for newly diagnosed EGFR-mutant non-small cell lung cancer. The combo will compete with AstraZeneca’s Tagrisso. J&J in-licensed Lazcluze, a third-generation EGFR tyrosine kinase inhibitor, from Korea’s Yuhan in 2018. The drug is now the first Korea-developed...