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NSCLC: FDA Breakthrough Therapy Designation for Targeted EGFR Inhibitor

A “breakthrough therapy” designation has been granted by the FDA to CLN-081 for the treatment of a subset of non-small cell lung cancer. The designation applies to use of the agent by patients with locally advanced or metastatic EGFR-mutated NSCLC who previously received chemotherapy and comes as a phase 1/phase 2a clinical trial is underway.