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FDA Brief: Novel EGFR Inhibitor Granted Breakthrough Therapy Designation in Lung Cancer

By: JNCCN 360 Staff
Posted: Friday, January 7, 2022

On January 4, 2022, the biopharmaceutical company Cullinan Oncology announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CLN-081 in the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR 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.

CLN-081 is the focus of a phase I/IIa trial (ClinicalTrials.gov identifier NCT04036682) in patients with NSCLC harboring exon 20 mutations whose disease has progressed on or after prior therapy. The goal of the trial is to determine the maximum tolerated dose and recommended phase II dose, as well as to evaluate preliminary efficacy. According to the manufacturer, the updated data from this ongoing trial suggest a “high response rate and encouraging progression-free survival” in heavily pretreated patients.



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