FDA record · Cancer
What FDA's own documents say about Datroway: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:”
Prescribing information, supplement 003 · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| TROPION-Breast01D9268C00001 | NCT05104866 | 3 | 69 | 9 of 13 |
| TROPION-PanTumor01DS1062-A-J101 | NCT03401385 | 1 | 21 | 4 of 13 |
| TROPION-Lung01DS1062-A-U301 | NCT04656652 | 3 | 16 | 3 of 13 |
| TROPION-Breast02D926PC00001 | NCT05374512 | 3 | 15 | 2 of 13 |
| TROPION-Lung05DS1062-A-U202 | NCT04484142 | 2 | 15 | 2 of 13 |
| TROPIONBreast01 | not given | 6 | 5 of 13 | |
| TROPiCS-02 | not given | 4 | 1 of 13 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
PFS
“The FDA agrees with the Applicant that TB01 demonstrated a statistically significant improvement in PFS, with a modest magnitude of effect [HR=0.63 (95% CI: 0.52, 0.76); median”
Multi-disciplinary Review · PDF p. 163 · fda.gov ↗
95%effect [HR=0.63
overall survival
“Median OS was 23.9 months in the T-DXd arm and 17.5 months in the chemotherapy arm (HR=0.64; 95% CI: 0.48, 0.86; p=0.0028).”
Multi-disciplinary Review · PDF p. 36 · fda.gov ↗
95%p=0.0028
PFS
“Median PFS was 5.5 months in the SG arm and 4 months in the chemotherapy arm (HR 0.661; 95% CI: 0.529, 0.826; p=0.0003); median OS was 14.4 months in the SG arm and”
Multi-disciplinary Review · PDF p. 36 · fda.gov ↗
95%p=0.0003
overall survival
“Overall, the observed final OS HR point estimate was close to 1 [HR=1.01 (95% CI: 0.83,”
Multi-disciplinary Review · PDF p. 154 · fda.gov ↗
estimate was close to 1 [HR=1.0195%
ORR
“There was an apparent positive exposure-ORR relationship, however, the logistic regression analysis indicated no significant exposure-ORR relationship (p > 0.001) with data from TB01.”
Multi-disciplinary Review · PDF p. 104 · fda.gov ↗
p > 0.001
“The most common adverse reactions (>=20%), including laboratory abnormalities, in patients with:”
Prescribing information, supplement 003 · PDF p. 1 · fda.gov ↗
“The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients >=90 kg) given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.”
Prescribing information, supplement 003 · PDF p. 1 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval761394s000lbl.pdf | January 17, 2025 | 17 | 82346274e789 | |
| Approval letter761394Orig1s000ltr.pdf | February 4, 2025 | 7 | 14b2e71a546b | |
| Administrative Correspondence761394Orig1s000AdminCorres.pdf | February 18, 2025 | 58 | archived copy | a7717b3f2d9a |
| Approval Letter761394Orig1s000Approv.pdf | February 18, 2025 | 10 | archived copy | 956dd02f1a0b |
| Chemistry Review761394Orig1s000ChemR.pdf | February 18, 2025 | 30 | archived copy | 6ec05b108db8 |
| Prescribing Information (Label)761394Orig1s000Lbl.pdf | February 18, 2025 | 21 | 689b81f9881e | |
| Multi-disciplinary Review761394Orig1s000MultidisciplineR.pdf | February 18, 2025 | 340 | e64424990624 | |
| Proprietary Name Review761394Orig1s000NameR.pdf | February 18, 2025 | 29 | a7eaad02f0b4 | |
| Officer/Employee List761394Orig1s000OEList.pdf | February 18, 2025 | 2 | 1fc4f85617d4 | |
| Other Reviews761394Orig1s000OtherR.pdf | February 18, 2025 | 42 | archived copy | 44cdddbcf774 |
| Risk Assessment / REMS Review761394Orig1s000RiskR.pdf | February 18, 2025 | 13 | archived copy | fbca953bb5ab |
| Approval letter, supplement 003761394Orig1s003ltr.pdf | May 27, 2026 | 4 | 2eb3104026a0 | |
| Prescribing information, supplement 003761394s003lbl.pdf | June 2, 2026 | 27 | 75914ef39a10 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.