Datopotamab Deruxtecan For Injection 100 mg Suppliers & Bulk Manufacturers

Available Forms: Lyophilised powder vial (IV infusion)

Available Strengths: 100 mg

Reference Brands: Datroway (Daiichi Sankyo / AstraZeneca)

Category: Oncology Cancer Care

Datopotamab deruxtecan (Datroway, Daiichi Sankyo and AstraZeneca) is a TROP2-directed antibody-drug conjugate for HR-positive, HER2-negative breast cancer and later lung cancer, approved in Japan, the US and the EU in 2024–25. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

Product Description:

Datopotamab deruxtecan is an antibody-drug conjugate (ADC). The antibody binds TROP2, a protein found on the surface of many breast and lung cancer cells, and carries a topoisomerase I inhibitor (deruxtecan) into the cell, where it is released and kills the cell. It uses the same payload technology as trastuzumab deruxtecan.

It was approved in Japan in December 2024, by the US FDA in January 2025 and in the EU in April 2025 as Datroway, first for HR-positive, HER2-negative breast cancer previously treated with endocrine therapy and chemotherapy. A US indication in previously treated EGFR-mutated non-small cell lung cancer followed. It is given by intravenous infusion every three weeks from 100 mg powder vials. Mouth sores and eye surface problems are typical side effects, so preventive mouthwash and eye care are part of treatment.

Sourcing and licensing notes. Datopotamab deruxtecan is patented and made only by Daiichi Sankyo with AstraZeneca; there is no biosimilar. It is a cold-chain product. We confirm registration status for each destination before quoting.