Patritumab Deruxtecan Demonstrated Statistically Significant
Sep 17, 2024 · Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.
Patritumab Deruxtecan Granted Priority Review in the U.S. for
Dec 22, 2023 · Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.
Patritumab Deruxtecan Demonstrated Statistically Significant ...
Sep 17, 2024 · The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement ...
Patritumab Deruxtecan BLA Submission Receives Complete …
Jun 26, 2024 · patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg
Patritumab Deruxtecan Granted Priority Review in the U.S. for …
Dec 22, 2023 · Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and...
Patritumab Deruxtecan Demonstrates a Manageable Safety …
Oct 19, 2023 · Patritumab deruxtecan is a novel, first-in-class, HER3-directed antibody drug conjugate (ADC). In HER3-expressing xenograft models, patritumab deruxtecan demonstrated antitumour responses across a range of baseline HER3 expression levels that …
Patritumab Deruxtecan Deemed Effective in Resistant,
Sep 12, 2023 · Patritumab deruxtecan (HER3-DXd) may overcome treatment resistance in patients with EGFR-mutant non-small cell lung cancer (NSCLC), according to trial results presented at the 2023 World ...
Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy …
Dec 23, 2021 · Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a fully human anti-HER3 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker.
FDA Grants Breakthrough Therapy Status to Patritumab Deruxtecan …
Jan 4, 2022 · Patritumab deruxtecan (U3-1402), a potential first-in-class HER3 directed antibody-drug conjugate, was granted breakthrough therapy designation by the FDA for the treatment of patients with metastatic or locally advanced, EGFR -mutant non–small cell lung cancer (NSCLC), according to a press release from developer Daiichi-Sankyo. 1.
Efficacy and Safety of Patritumab Deruxtecan in Patients with.
Sep 29, 2023 · Patritumab deruxtecan demonstrated clinically meaningful efficacy, including durable intracranial responses, with a manageable safety profile in patients with previously treated EGFR-mutated NSCLC.