FDA Approves Datroway (datroway) for EGFR-Mutated NSCLC and HR+ Breast Cancer

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FDA Published May 26, 2026 Medically reviewed May 26, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider Datroway for EGFR-mutated NSCLC after prior EGFR therapy and platinum chemo, and for HR+/HER2- breast cancer after endocrine and chemo.

The FDA has approved Datroway (datroway), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for two distinct indications. First, it is indicated for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication received accelerated approval based on objective response rate and duration of response, with continued approval contingent on verification of clinical benefit in a confirmatory trial. Second, Datroway is approved for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval provides a new treatment option for these patient populations, particularly those with limited alternatives after progression on standard therapies.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Datroway is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. The antibody component binds to Trop-2 on cancer cells, and after internalization, the topoisomerase inhibitor payload is released, leading to DNA damage and cell death.

Indication & Patient Population

Datroway is indicated for: - Adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. - Adult patients with unresectable or metastatic, HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Dosing & Administration

The recommended dosage is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) administered as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity. Dose reductions are recommended for adverse reactions: first reduction to 4 mg/kg (max 360 mg), second to 3 mg/kg (max 270 mg), and permanently discontinue if unable to tolerate 3 mg/kg. Premedication includes preservative-free lubricant eye drops, steroid-containing mouthwash, antihistamine, antipyretic, and antiemetics. Reconstitute with Sterile Water for Injection and dilute with 5% Dextrose Injection; do not use Sodium Chloride Injection.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Datroway provides a targeted therapy option for patients with EGFR-mutated NSCLC after progression on EGFR-directed therapy and platinum-based chemotherapy, and for patients with HR-positive, HER2-negative breast cancer after endocrine-based therapy and chemotherapy. The NSCLC indication is under accelerated approval, requiring confirmatory trials to verify clinical benefit.

Study Details

Study typeFda approval

PublishedJan 2025

View Original Abstract ↓

1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. ( 1.2 ) 1.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. 1.2 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.