Posted by Michael Wonder on 05 Jan 2022
FDA grants breakthrough therapy designation for Cullinan Oncology’s CLN-081 in patients with locally advanced or metastatic EGFR mutated non-small-cell lung cancer
4 January 2022 - Cullinan Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer harbouring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
CLN-081 is an orally available, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
