Trastuzumab deruxtecan (Enhertu, T-DXd) is a treatment for breast cancer, advanced stomach cancer, non-small cell lung cancer, and solid tumors. Includes side effects, FDA approval, package insert, and more.
Moreover, the median overall survival (OS) with trastuzumab deruxtecan was 23.4 months (95% CI, 20.0-24.8) vs 16.8 months (95% CI, 14.5-20.0) with chemotherapy in all patients; this translated to a 36% reduction in the risk of death with the antibody-drug conjugate (ADC; HR, 0.64; ...
Moreover, trastuzumab deruxtecan elicited an objective response rate (ORR) of 79% (95% CI, 73.1%-83.4%) by BICR compared with 35% (95% CI, 29.2%-41.1%) with trastuzumab emtansine. Of those who responded to trastuzumab deruxtecan, 21% achieved a complete response and 57% had a...
In DESTINY-Breast 03, Trastuzumab Deruxtecan, a HER2-specific antibody-drug conjugate, proved superior to T-DM1 in patients with HER2+ metastatic breast cancer progressing on taxane and trastuzumab.1 This study supported its recent approval as second-line therapy in HER2+ metastatic breast cancer....
(another humanized monoclonal antibody that binds to the domain II of HER2) as the first-line therapy for metastatic HER2-positive breast cancer by the FDA in 2012[15], more potent trastuzumab-based drugs like antibody–drug conjugates (ADCs) (trastuzumab deruxtecan[T-DXd] and trastuzumab ...
The US Food and Drug Administration (FDA) has granted standard approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positivebreast cancerwho have received one prior anti-HER2 therapy. Thisstandard approvalconverts a December 2019accelerated approvalfor...
Fam-trastuzumab deruxtecan-nxki has been granted an accelerated approval by the FDA for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least 2 prior lines of anti–HER2-based regimens in the metastatic setting....
Fam-trastuzumab deruxtecan Pregnancy Warnings Use should be avoided. AU TGA pregnancy category: D US FDA pregnancy category: Not assigned. Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. The topoisomerase inhibitor component of...
Abbreviations: ADC, antibody-drug conjugate; DXd, deruxtecan; HER2, human epidermal growth factor receptor 2; IgG1, immunoglobulin G1; mAb, monoclonal antibody; T-DXd, trastuzumab deruxtecan. EXPERT OPINION ON BIOLOGICAL THERAPY 815 In a phase 1 drug–drug interaction study (DS8201-A-A104),...
AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ ...