FDA

FDA greenlights Datroway for advanced breast cancer

January 24, 2025

Brand name: Datroway

Generic name: datopotomab deruxtecan-dlnk

Manufacturer: AstraZeneca and Daiichi Sankyo

Approval date: January 17, 2025

FDA approved Datroway (datopotamab deruxtecan-dlnk), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adults with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who’ve received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Efficacy

Approval was based on data from the phase 3 randomized, open-label TROPION-Breast01 trial (NCT05104866). Participants must have experienced disease progression, been deemed unsuitable for further endocrine therapy, and have received one or two lines of prior chemotherapy for unresectable or metastatic disease.

A total of 732 patients were randomized (1:1) to datopotamab deruxtecan-dlnk (n=365) or investigator’s choice of chemotherapy (n=367): eribulin (60%), capecitabine (21%), vinorelbine (10%), or gemcitabine (9%).

The major efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Additional efficacy outcomes included confirmed objective response rate (ORR) and duration of response (DOR). Median PFS was 6.9 months (95% CI, 5.7-7.4) in the datopotamab deruxtecan-dlnk arm and 4.9 months (95% CI, 4.2-5.5) in the chemotherapy arm (hazard ratio [HR], 0.63; 95% CI, 0.52-0.76; two-sided p-value <0.0001). Median OS was 18.6 months (95% CI, 17.3-20.1) in the datopotamab deruxtecan-dlnk arm and 18.3 months (95% CI, 17.3-20.5) in the chemotherapy arm (HR, 1.01; 95% CI, 0.83-1.22; two-sided p-value wasn’t statistically significant). Confirmed ORR was 36% (95% CI, 31-42) and 23% (95% CI, 19-28) and median DOR was 6.7 months (95% CI, 5.6-9.8) and 5.7 months (95% CI, 4.9-6.8) in the datopotamab deruxtecan-dlnk and chemotherapy arms, respectively.

Safety

The most common adverse reactions (≥20%) were stomatitis; nausea and vomiting; fatigue; decreased leukocytes, lymphocytes, neutrophils, hemoglobin, calcium; alopecia; constipation; dry eye and keratitis; increased ALT, AST, and alkaline phosphatase.

Recommended dose

The recommended dosage of datopotamab deruxtecan-dlnk is 6 mg/kg (max: 540 mg for patients ≥90 kg), administered as an IV infusion, q3wks (21-day cycle), until disease progression or unacceptable toxicity.

Sources:

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer. Food and Drug Administration. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast

Datroway® (datopotamab deruxtecan-dlnk) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer. AstraZeneca. 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/dato-dxd-approved-in-us-for-hr-p-breast-cancer.html

Datroway. Package insert. AstraZeneca. 2025. Accessed January 23, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf