SAFETY
DATROWAY has serious Warnings and Precautions. Click here for more information.
Safety data from TROPION-Breast01 demonstrated the benefit-risk profile of DATROWAY1,2
The majority of common adverse reactions with DATROWAY were Grade 1 or 2
Adverse reactions (≥10%) in patients who received DATROWAY in TROPION-Breast011
| DATROWAY (n=360) | Chemotherapy (n=351) | ||||
|---|---|---|---|---|---|
| Adverse reactions, % | All Grades | Grades 3 or 4 | All Grades | Grades 3 or 4 | |
| Gastrointestinal disorders |
Stomatitisa | 59 | 7 | 17 | 2.6 |
| Nausea | 56 | 1.4 | 27 | 0.6 | |
| Constipation | 34 | 0.3 | 17 | 0 | |
| Vomiting | 24 | 1.1 | 12 | 1.1 | |
| Diarrhea | 11 | 0.6 | 19 | 1.4 | |
| Abdominal paina | 11 | 0.6 | 15 | 1.4 | |
| General disorders | Fatigueb | 44 | 4.2 | 40 | 3.7 |
| Skin and subcutaneous tissue disorders |
Alopecia | 38 | 0 | 22 | 0 |
| Rasha | 19 | 0 | 17 | 2.3 | |
| Eye disorders | Dry eye | 27 | 0.8 | 13 | 0 |
| Keratitisc | 24 | 1.1 | 10 | 0 | |
| Metabolism and nutrition disorders |
Decreased appetite | 16 | 1.4 | 16 | 0.9 |
| Infections and infestations |
COVID-19a | 16 | 1.4 | 13 | 0.9 |
| Respiratory, thoracic, and mediastinal disorders |
Cougha | 15 | 0 | 10 | 0 |
| DATROWAY (n=360) | Chemotherapy (n=351) | |||
|---|---|---|---|---|
| Adverse reactions, % | All Grades | Grades 3 or 4 | All Grades | Grades 3 or 4 |
| Gastrointestinal disorders | ||||
| Stomatitisa | 59 | 7 | 17 | 2.6 |
| Nausea | 56 | 1.4 | 27 | 0.6 |
| Constipation | 34 | 0.3 | 17 | 0 |
| Vomiting | 24 | 1.1 | 12 | 1.1 |
| Diarrhea | 11 | 0.6 | 19 | 1.4 |
| Abdominal paina | 11 | 0.6 | 15 | 1.4 |
| General disorders | ||||
| Fatigueb | 44 | 4.2 | 40 | 3.7 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 38 | 0 | 22 | 0 |
| Rashd | 19 | 0 | 17 | 2.3 |
| Eye disorders | ||||
| Dry eye | 27 | 0.8 | 13 | 0 |
| Keratitisc | 24 | 1.1 | 10 | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 16 | 1.4 | 16 | 0.9 |
| Infections and infestations | ||||
| COVID-19a | 16 | 1.4 | 13 | 0.9 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cougha | 15 | 0 | 10 | 0 |
Events were graded using National Cancer Institute Common Terminology Criteria (NCI CTCAE) version 5.0.1
aIncludes other related terms.1
bIncludes fatigue, asthenia, lethargy, malaise.1
cIncludes corneal disorder, corneal erosion, corneal infiltrates, corneal lesion, corneal toxicity, injury corneal, keratitis, keratopathy, punctate keratitis, and ulcerative keratitis.1
Grade ≥3 TRAEs1,2
21%
with DATROWAY
45%
with chemotherapy
- Serious adverse reactions occurred in 15% of patients with DATROWAY
Discontinuation rate due to ARs1
3%
with DATROWAY
- Dosage interruptions and dose reductions of DATROWAY due to ARs occurred in 22% and 23% of patients, respectively
TRAEs refer to adverse events possibly related to treatment as assessed by the investigator. Adverse reactions refer to adverse events which have a likely basis for a causal relationship between the drug and the occurrence of the adverse event.2,3
Grade ≥3 neutropenia was 1% with DATROWAY and 31% with chemotherapy. 3% of patients on DATROWAY and 22% of patients on chemotherapy required G-CSF treatment.2
Select TRAEs in TROPION-Breast012,4-6
In TROPION-Breast01, the majority of select TRAEs with DATROWAY were Grade 1 or 2
| DATROWAY (n=360) | Chemotherapy (n=351) | |||||||
|---|---|---|---|---|---|---|---|---|
| Select TRAEs, % | Grade 1 | Grade 2 | Grade ≥3 | Discontinuation rate | Grade 1 | Grade 2 | Grade ≥3 | Discontinuation rate |
| Stomatitis | 25 | 23 | 7 | 0.3 | 9 | 3.4 | 2.6 | 0 |
| Adjudicated drug-related ILDd |
1.4 | 1.1 | 0.8 | 1.4 | 0 | 0 | 0 | 0 |
| Keratitis | 11 | 2.5 | 0.6 | 0 | 4 | 0.9 | 0 | 0 |
| Dry eye | 19 | 1.9 | 0.6 | 0.3 | 7 | 0.9 | 0 | 0 |
| Alopecia | 21 | 15 | 0 | 0 | 10 | 10 | 0 | 0 |
| Select TRAEs, % |
DATROWAY (n=360) | |||
|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade ≥3 | Discontinuation rate | |
| Stomatitis | 25 | 23 | 7 | 0.3 |
| Adjudicated drug-related ILDd |
1.4 | 1.1 | 0.8 | 1.4 |
| Keratitis | 11 | 2.5 | 0.6 | 0 |
| Dry eye | 19 | 1.9 | 0.6 | 0.3 |
| Alopecia | 21 | 15 | 0 | 0 |
| Chemotherapy (n=351) | ||||
|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade ≥3 | Discontinuation rate | |
| Stomatitis | 9 | 3.4 | 2.6 | 0 |
| Adjudicated drug-related ILDd |
0 | 0 | 0 | 0 |
| Keratitis | 4 | 0.9 | 0 | 0 |
| Dry eye | 7 | 0.9 | 0 | 0 |
| Alopecia | 10 | 10 | 0 | 0 |
dOne patient had an adjudicated drug-related Grade 5 ILD event with DATROWAY.2
-
Defining Grade 1-2 select adverse reactionsStomatitis6
- Grade 1: Asymptomatic or mild symptoms; intervention not indicated
- Grade 2: Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
ILD/pneumonitis1,6- Grade 1: Asymptomatic; consider corticosteroid treatment
- Grade 2: Symptomatic; promptly initiate corticosteroid treatment; limiting instrumental activities of daily living
Keratitis6- Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated
- Grade 2: Symptomatic; moderate decrease in visual acuitye
Dry eye6- Grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; symptoms relieved by lubricants
- Grade 2: Symptomatic; moderate decrease in visual acuitye
Alopecia6- Grade 1: Hair loss of <50%f
- Grade 2: Hair loss of ≥50% normal for individual; readily apparent to othersg
eBest corrected visual ability 20/40 and better or 3 lines or less decreased vision from known baseline.6
fA different hair style may be required to cover the hair loss but does not require a wig or hair piece to camouflage.6
gA wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss; associated with psychological impact.6
Warnings and Precautions1
ILD/pneumonitish
- DATROWAY can cause severe and fatal cases of ILD/pneumonitis
- ILD/pneumonitis occurred in 4.2% of patients, including 0.5% with Grade 3 or 4, and 0.3% with fatal Grade 5 events. Median time to onset was 3.5 months (range: 1.2-10.8 months). Discontinuation due to ILD/pneumonitis occurred in 1.7% of patients
Ocular adverse reactions
- DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision
- Ocular adverse reactions occurred in 51% of patients, including 1.9% of patients experiencing a Grade 3 event (including dry eye, keratitis, and blurred vision). Median time to onset was 2.1 months (range: 0.03-23.2 months). Discontinuation due to ocular adverse reactions occurred in 0.8% of patients
Stomatitis
- DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis
- Stomatitis occurred in 59% of patients, including 7% of patients with Grade 3 or 4 events. Median time to onset was 0.7 months (range: 0.03-8.8 months). Stomatitis led to interruption of DATROWAY in 1.9%, dosage reductions in 13%, and permanent discontinuations in 0.3% of patients
Embryo-fetal toxicity
- DATROWAY can cause embryo-fetal harm
hA higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min).1
-
Additional safety data for DATROWAY1
Median duration of treatment was 6.7 months (range: 0.7-16.1 months).
Serious adverse reactions- Serious adverse reactions (>0.5% of patients) were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients and were due to ILD/pneumonitis
Adverse reactions associated with discontinuations and dose modifications- Discontinuation (>0.5% of patients) included ILD/pneumonitis (1.7%) and fatigue (0.6%)
- Dosage interruption (>1% of patients) included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%)
- Dose reduction (>1% of patients) included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%)
Other clinically relevant adverse reactions in <10% of patients- Infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis
Select laboratory abnormalities (≥20%) in patients who received DATROWAY in TROPION-Breast011
| DATROWAY (n=360)i | Chemotherapy (n=351)i | ||||
|---|---|---|---|---|---|
| Laboratory abnormality, % | All Grades | Grades 3 or 4 | All Grades | Grades 3 or 4 | |
| Hematology | Decreased leukocytes | 41 | 1.1 | 63 | 18 |
| Decreased lymphocytes | 36 | 9 | 42 | 11 | |
| Decreased hemoglobin | 35 | 2.8 | 51 | 4.4 | |
| Decreased neutrophils | 30 | 1.6 | 61 | 35 | |
| Chemistry | Decreased calcium | 39 | 1.4 | 43 | 1.2 |
| Increased AST | 23 | 1.9 | 28 | 0.9 | |
| Increased ALT | 24 | 1.7 | 31 | 0.6 | |
| Increased alkaline phosphate | 23 | 0.6 | 20 | 0.6 | |
| DATROWAY (n=360)i | Chemotherapy (n=351)i | |||
|---|---|---|---|---|
| Laboratory abnormality, % | All Grades | Grades 3 or 4 | All Grades | Grades 3 or 4 |
| Hematology | ||||
| Decreased leukocytes | 41 | 1.1 | 63 | 18 |
| Decreased lymphocytes | 36 | 9 | 42 | 11 |
| Decreased hemoglobin | 35 | 2.8 | 51 | 4.4 |
| Decreased neutrophils | 30 | 1.6 | 61 | 35 |
| Chemistry | ||||
| Decreased calcium | 39 | 1.4 | 43 | 1.2 |
| Increased AST | 23 | 1.9 | 28 | 0.9 |
| Increased ALT | 24 | 1.7 | 31 | 0.6 |
| Increased alkaline phosphate | 23 | 0.6 | 20 | 0.6 |
iThe denominator used to calculate the rate varied from 264 to 359 based on the number of patients with a baseline value and at least one post-treatment value. Frequencies were based on NCI CTCAE v.5.0 grade-derived laboratory abnormalities.1
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