FDA Approves DATROWAY® for Advanced HR+/HER2- Breast Cancer

A new breast cancer treatment option

The United States Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) on January 17, 2025, for adults with hormone receptor-positive (HR+), HER2-negative breast cancer that is unresectable or metastatic and has already been treated with both endocrine therapy and chemotherapy.

What is DATROWAY?

DATROWAY is a Trop-2-directed antibody-drug conjugate that delivers a chemotherapy payload directly to cancer cells. It was developed by Daiichi Sankyo, Inc.

Administration

DATROWAY is administered via IV infusion once every 3 weeks.

Clinical Trial Snapshot

• Trial Name: TROPION-Breast01
• Patients: 732 (across 20 countries; 59 from the U.S.)
• Design: Compared DATROWAY vs. chemotherapy
• Key Results:
• Progression-Free Survival (PFS):
• DATROWAY: 6.9 months
• Chemotherapy: 4.9 months
• Also showed improved response rates and duration of response.

Potential Side Effects

DATROWAY may cause:

• Severe lung problems, including life-threatening or fatal interstitial lung disease (ILD)
• Mouth sores, eye irritation, keratitis
• Risk to unborn babies

Most common side effects include:

• Mouth ulcers, nausea, fatigue
• Low white/red blood cell counts, hair loss
• Constipation, dry eyes, liver enzyme elevation

Summary

DATROWAY offers a new treatment option for patients with difficult-to-treat HR+/HER2- breast cancer, showing better cancer control than standard chemo — but it carries significant risks that must be carefully managed.

Editor’s Note: This is another in our series of potentially game-changing novel pharmaceuticals that FDA approved in 2024 and 2025. This approval report does not in any way recommend or promote this product. For more information contact your oncologist or the manufacturer. Report any adverse effects experienced with this product to FDA’s Medwatch System.

More approved novel drugs

DATROWAY drug trials snapshot