Datroway (datopotamab deruxtecan) is an innovative Trop-2-directed antibody-drug conjugate (ADC) that provides a new treatment option for patients with specific types of metastatic breast cancer. Combining the precision of targeted therapy with the potent cytotoxic effects of chemotherapy, this drug exerts antitumor activity through a unique dual mechanism.

What Are the Indications for Datroway (Datopotamab Deruxtecan)?

Unresectable or Metastatic HR-Positive, HER2-Negative Breast Cancer

Datroway is specifically indicated for the treatment of unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adult patients.

These patients must have a molecular subtype of IHC 0, IHC 1+, or IHC 2+/ISH- as determined by immunohistochemical (IHC) testing, and require further treatment after receiving endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Prior Treatment Requirements

Eligible patients must have received endocrine therapy and chemotherapy for unresectable or metastatic disease, indicating that Datroway is primarily used in second-line or subsequent treatment settings.

Dosage Form, Specification, and Properties of Datroway (Datopotamab Deruxtecan)

Dosage Form and Specification

Datroway is supplied as a lyophilized powder for injection.

Each single-dose vial contains 100 mg of datopotamab deruxtecan-dlnk, a white to off-white lyophilized powder.

Each vial contains 100 mg of the active ingredient, along with excipients including L-histidine (3.88 mg), L-histidine hydrochloride monohydrate (5.25 mg), polysorbate 80 (1.50 mg), and sucrose (450 mg).

Physicochemical Properties

After reconstitution, the lyophilized powder forms a clear, colorless to pale yellow solution.

The reconstituted solution has a pH of 6.0 and a concentration of 20 mg/mL.

This product is a sterile formulation without preservatives and must be handled under strictly sterile conditions.

Structural Characteristics

Datopotamab deruxtecan-dlnk is an antibody-drug conjugate composed of three main components: a humanized anti-Trop2 IgG1 monoclonal antibody covalently linked to a topoisomerase inhibitor via a tetrapeptide-based cleavable linker.

Approximately 4 deruxtecan molecules are conjugated to each antibody molecule.

Preparatory Inspection

A visual inspection must be performed before administration to check for the presence of particles, turbidity, or discoloration.

Do not use if these abnormalities are found, or if the packaging, vial, or related components are expired, damaged, or tampered with.

Storage Conditions for Datroway (Datopotamab Deruxtecan)

Routine Storage Requirements

Datroway must be stored refrigerated at 2°C to 8°C (36°F to 46°F), with strict avoidance of freezing.

Both unopened vials and reconstituted solutions should be kept in the original carton to protect from light.

Reconstitution Specifications

Slowly inject 5 mL of sterile water for injection into each 100 mg vial using a sterile syringe.

Gently swirl the vial until complete dissolution; vigorous shaking is strictly prohibited.

If not used immediately, the reconstituted solution may be stored refrigerated at 2°C to 8°C for a maximum of 24 hours.

Any unused reconstituted solution must be discarded within 24 hours of reconstitution.

Dilution and Storage

Dilute with 100 mL of 5% dextrose injection; normal saline (sodium chloride injection) is strictly prohibited.

The diluted solution is compatible with infusion bags made of polyvinyl chloride (PVC) or polyolefin.

The diluted solution may be stored at room temperature (maximum 25°C/77°F) for up to 4 hours, or refrigerated at 2°C to 8°C for up to 24 hours.

Protect from light and avoid freezing throughout the entire process.

Administration Time Limits

The total time from vial reconstitution to the end of administration should not exceed 24 hours.

If storage exceeds these limits, the solution must be discarded.

Hazardous Drug Management

Datroway is classified as a hazardous drug and must be handled and disposed of in accordance with applicable special procedures.

Operators should receive appropriate training and wear suitable personal protective equipment to ensure all operational steps are performed under safe conditions.

Temperature Control

If the prepared infusion solution is stored refrigerated at 2°C to 8°C, it should be allowed to reach room temperature under light protection before administration.