Datopotamab (Datroway) is a novel Trop-2-directed antibody-drug conjugate (ADC) linked to a topoisomerase inhibitor. Developed by Daiichi Sankyo Co., Ltd., it was first approved for marketing in the United States in 2025. As a targeted therapeutic agent, it provides a new treatment option for patients with specific types of breast cancer.

Indications of Datopotamab (Datroway)

Treatment of HR-positive/HER2-negative Breast Cancer

(1) The main indication of datopotamab is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

(2) It is indicated for patients who have progressed after receiving endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Specifications and Properties of Datopotamab (Datroway)

Basic Dosage Form Characteristics

(1) Datopotamab is supplied as a lyophilized powder for injection.

(2) It is packaged in single-dose vials, with each vial containing 100 mg of the active ingredient datopotamab deruxtecan-dlnk.

(3) Its appearance is a white to yellowish-white lyophilized powder.

(4) After reconstitution, it forms a clear, colorless to pale yellow solution.

(5) It is an isotonic solution with a pH of 6.0.

Characteristics After Reconstitution

(1) The drug must be reconstituted and further diluted before use.

(2) Each 100 mg vial should be reconstituted by adding 5 mL of sterile water for injection.

(3) The concentration after reconstitution is 20 mg/mL.

(4) The reconstituted solution contains no preservatives and must be used within 24 hours.

Compatibility Characteristics

(1) For dilution, 5% dextrose injection must be used; sodium chloride injection is prohibited.

(2) Compatible infusion bag materials are polyvinyl chloride (PVC) or polyolefins (polypropylene or ethylene-propylene copolymer).

(3) A 0.2-micron in-line filter made of polytetrafluoroethylene (PTFE), polyethersulfone (PES), or nylon 66 must be used.

Storage Requirements for Datopotamab (Datroway)

Storage of Unopened Original Packaging

(1) Storage temperature: Refrigerate at 2°C to 8°C (36°F to 46°F).

(2) Must be kept in the original packaging to protect from light.

(3) Freezing is strictly prohibited.

Storage After Reconstitution

(1) The reconstituted solution can be refrigerated (2°C to 8°C) for no more than 24 hours.

(2) It can be stored at room temperature (not exceeding 25°C) for no more than 4 hours.

(3) Store protected from light.

(4) Freezing of the reconstituted solution is strictly prohibited.

Diluted Infusion Solution

(1) The total time from reconstitution to the end of administration must not exceed 24 hours.

(2) If stored under refrigeration, it should be warmed to room temperature before use.

(3) The infusion bag must be covered to protect from light during the infusion process.