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FDA Grants Priority Review to AZ's Datroway for Metastatic Triple Negative Breast Cancer
DATROWAY showed a 5-month median overall survival improvement and 43% risk reduction in progression or death for immunotherapy-ineligible metastatic triple-negative breast cancer patients.
- The FDA granted Priority Review to DATROWAY for unresectable or metastatic TNBC on Feb 3, 2026, with a decision expected by June 2, 2026.
- The Phase III trial demonstrated a statistically significant five-month improvement in median overall survival and a 43% reduction in risk of progression or death versus investigator's choice chemotherapy, while approximately 70% of metastatic TNBC patients are ineligible for immunotherapy.
- In the trial, DATROWAY achieved an objective response rate of 62.5% and duration of response of 12.3 months versus chemotherapy ORR 29.3% and DoR 7.1 months, and among 927 patients, 45% were exposed six months or longer.
- AstraZeneca said DATROWAY could become the standard of care in first-line metastatic TNBC, though continued approval may require verification in a confirmatory trial.
- Clinicians should monitor patients for respiratory symptoms as DATROWAY can cause severe interstitial lung disease /pneumonitis, with dosage interruptions in 43%, permanent discontinuation in 8%, and fatal adverse reactions reported.
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Total News Sources12
Leaning Left2Leaning Right0Center3Last UpdatedBias Distribution60% Center
Bias Distribution
- 60% of the sources are Center
60% Center
L 40%
C 60%
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