On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for...

Jan 17, 2025 · The recommended datopotamab deruxtecan-dlnk dose is 6 mg/kg (maximum of 540 mg for patients ≥90 kg), administered as an intravenous infusion, once every 3 weeks (21-day cycle), until disease progression or unacceptable toxicity. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Datopotamab deruxtecan-dlnk is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-Trop2 IgG1 monoclonal antibody (mAb), covalently linked to 2) a topoisomerase I...

2 days ago · Datopotamab deruxtecan-dlnk is an antibody-drug conjugate (an antibody with a cell-killing medication attached to it) directed against a protein called Trop-2 (trophoblast cell surface antigen 2), found on the surface of some cancer cells. Antibodies, which are normally found in the body, are developed by the immune system to destroy foreign material (such as a germ). …

Jan 21, 2025 · Datroway (datopotamab deruxtecan-dlnk) is commonly used to treat certain types of breast cancer. Datroway may also be used for other conditions as determined by your healthcare provider.

Datopotamab deruxtecan, sold under the brand name Datroway, is an anti-cancer medication used for the treatment of breast cancer. [1][2] It is a Trop-2 -directed antibody and topoisomerase inhibitor antibody-drug conjugate. [1][2]

Jan 13, 2025 · Datopotamab deruxtecan was previously granted Breakthrough Therapy Designation (BTD) by the FDA for this patient population. The BLA and BTD are based on data from the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial. In addition, the BLA is supported by data from the TROPION-PanTumor01 …

Dec 9, 2024 · Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform.

Apr 23, 2024 · Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent, exatecan-derived topoisomerase I inhibitor payload via a …

Aug 21, 2021 · We developed the novel TROP2-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd, DS-1062a), with a potent DNA topoisomerase I inhibitor (DXd), and eva …