Posted by Michael Wonder on 27 Dec 2023
FDA grants fast track designation to Henlius’ EGFR targeting ADC HLX42 for NSCLC patients with disease progression on EGFR targeted therapies
27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR targeting antibody drug conjugate that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with advanced or metastatic EGFR mutated non-small cell lung cancer whose disease has progressed on a third generation EGFR tyrosine kinase inhibitor.
Previously, HLX42 was approved for conducting clinical trial by the National Medical Products Administration and the FDA.
