Posted by Michael Wonder on 26 Dec 2021
Patritumab deruxtecan granted U.S. FDA breakthrough therapy designation in patients with metastatic EGFR mutated non-small-cell lung cancer
23 December 2021 - First breakthrough therapy designation for patritumab deruxtecan based on results of Phase 1 trial.
Daiichi Sankyo announced that the U.S. FDA has granted breakthrough therapy designation to patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed antibody drug conjugate, for the treatment of patients with metastatic or locally advanced EGFR mutated non-small cell lung cancer with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor and platinum-based therapies.
