Patritumab deruxtecan FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 15, 2024.
FDA Approved: No
Generic name: patritumab deruxtecan
Company: Daiichi Sankyo and Merck
Treatment for: Non Small Cell Lung Cancer
Patritumab deruxtecan (HER3-DXd) is a first-in-class HER3 directed DXd antibody drug conjugate in development for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
- The EGFR mutation is a common mutation in non-small cell lung cancer (NSCLC). Targeted therapy of EGFR mutated NSCLC includes the use of EGFR tyrosine kinase inhibitors (TKIs) but most patients eventually develop resistance to these treatments. The HER3 protein is a member of the EGFR family of receptor tyrosine kinases and it is thought that 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment. There are currently no HER3-directed agents approved by the FDA.
- Patritumab deruxtecan is a potential first-in-class HER3 directed antibody drug conjugate (ADC) comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.
- In December 2023, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
- The BLA was based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial and data results presented at the IASLC 2023 World Conference on Lung Cancer (#WCLC23), which were simultaneously published in the Journal of Clinical Oncology.
- Breakthrough Therapy Designation was granted by the FDA in December 2021. The Prescription Drug User Fee Act (PDUFA) date is June 26, 2024.
Development timeline for patritumab deruxtecan
Further information
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