Frequently asked questions about DATROWAY^®

DATROWAY is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop-2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker.¹

Learn more about how DATROWAY may work on the MOA page.

DXd, deruxtecan; IgG, immunoglobulin G; MOA, mechanism of action; Trop-2, trophoblast cell surface antigen 2.

DATROWAY is indicated for¹:

• DATROWAY is indicated for the treatment of 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial

Learn more about DATROWAY in EGFRm mNSCLC.

• DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy

Learn more about DATROWAY in mTNBC.

• DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, HR+, HER2– (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

Learn more about DATROWAY in HR+/HER2– mBC.

EGFRm, epidermal growth factor receptor-mutated; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; mBC, metastatic breast cancer; mNSCLC, metastatic non-small cell lung cancer; mTNBC, metastatic triple-negative breast cancer; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, programmed cell death-ligand 1; TNBC, triple-negative breast cancer.

No.¹

Warnings and precautions for DATROWAY include¹: 

• ILD/pneumonitis  
• Ocular adverse reactions    
• Stomatitis  
• Embryo-fetal toxicity   

View the full safety profile for DATROWAY in mTNBC, HR+/HER2– mBC, and EGFRm mNSCLC.

EGFRm, epidermal growth factor receptor-mutated; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; ILD, interstitial lung disease; mBC, metastatic breast cancer; mNSCLC, metastatic non-small cell lung cancer; mTNBC, metastatic triple-negative breast cancer.

Ocular adverse reactions¹

• Advise patients to use preservative-free lubricant eye drops at least 4 times daily and as needed
• Refer patients to an eye care professional (optometrist or ophthalmologist) for an ophthalmic exam* at treatment initiation, at end of treatment, and as clinically indicated
• While on treatment, conduct visual acuity testing and slit lamp examination every 3 cycles
• Advise patients to avoid using contact lenses during treatment unless directed by an eye care professional

Exam to include visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy.¹

Oral mucositis/stomatitis^1-5

• When starting DATROWAY, and throughout treatment, advise patients to use dexamethasone oral solution 0.1 mg/mL (or similar steroid-containing mouthwash) for prophylaxis 4 times daily and as needed^†
• Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion

Prophylaxis was recommended but not mandated in the trials because it was not globally available.^3,4,6,7

^†In patients who received DATROWAY, 51% and 39% used a mouthwash containing a corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during treatment in TROPION-Breast02 and TROPION-Breast01, respectively.¹

Infusion-related reactions¹

• Administer premedication, including antihistamines and antipyretics, 30-60 minutes prior to each infusion
  • Example: Diphenhydramine 25-50 mg and acetaminophen 650-1000 mg intravenously or orally

Nausea and vomiting¹

• Antiemetic agents prior to each infusion and thereafter, as needed
  • Example: 5-HT3 serotonin receptor antagonist or appropriate alternatives intravenously or orally

Each patient is unique; when treating with DATROWAY, consider institutional guidelines.

Learn more on the AR Management page or download the Managing Select Adverse Reactions Leave Behind or Ocular Assessment Form (to be shared with optometrist or ophthalmologist to support ocular exams).

Refer patients to an eye care professional (optometrist or ophthalmologist) for an ophthalmic exam* at treatment initiation, at end of treatment, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions.¹

Learn more on the AR Management page or download the Managing Select Adverse Reactions Leave Behind or Ocular Assessment Form (to be shared with optometrist or ophthalmologist to support ocular exams).

*Exam to include visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy.¹

AR, adverse reaction.

The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) administered as intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.¹

The first infusion should be administered over 90 minutes. Subsequent infusions may be reduced to 30 minutes if prior infusions were tolerated.¹

Monitor patients during infusion and for at least 1 hour post-infusion for first 2 cycles and 30 minutes post-infusion for subsequent cycles if there are no infusion-related reactions observed.¹

See the full dosing and administration details.

If a planned dose is delayed or missed, administer as soon as possible; do not wait until the next planned cycle. Adjust the schedule of administration to maintain a 3-week interval between doses.¹

For more information, visit the Dosing page and AR Management page.

AR, adverse reaction.

Adverse reactions should be managed with dose delays, reductions, or discontinuations, as needed.

See the table below for recommended dose reduction schedule for adverse reactions with DATROWAY.

Recommended dose reduction schedule of DATROWAY for ARs¹: 

Do not re-escalate the DATROWAY dose after a dose reduction. Permanently discontinue DATROWAY in patients who are unable to tolerate 3 mg/kg intravenously once every 3 weeks.¹

For more information, visit the Dosing page and AR Management page.

AR, adverse reaction; IV, intravenous.

The HCPCS code, or J-code, for DATROWAY is J9011.

Learn more about access and support with DATROWAY.

HCPCS, Healthcare Common Procedure Coding System.

Visit the Care Team Corner page to download resources to support your patients and your practice or request a DATROWAY Starter Kit.

Visit the Access & Support page for resources to help your patients access DATROWAY, including the DATROWAY4U patient access hub.

DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.¹

Learn more about DATROWAY in mTNBC.

DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, HR+, HER2– (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

Learn more about DATROWAY in HR+/HER2–mBC.

HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; mBC, metastatic breast cancer; mTNBC, metastatic triple-negative breast cancer; PD-1, programmed cell death protein 1; PD-L1, programmed cell death-ligand 1; TNBC, triple-negative breast cancer.

TROPION-Breast02 was a multicenter, open-label, randomized trial of 644 patients with unresectable or metastatic TNBC who had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer. Patients must not have been candidates for PD-1/PD-L1 inhibitor therapy. Patients were randomized 1:1 to receive either DATROWAY Q3W (n=323) or chemotherapy (n=321). The major efficacy outcomes were PFS (BICR) and OS. The trial had a broad patient population, including patients with DFI <6 months (15%) and stable brain metastases (10%).¹

See the full study design for TROPION-Breast02.

BICR, Blinded Independent Central Review; DFI, disease-free interval; mTNBC, metastatic triple-negative breast cancer; OS, overall survival; PD-1, programmed cell death protein 1; PD-L1, programmed cell death-ligand 1; PFS, progression-free survival; Q3W, once every 3 weeks; TNBC, triple-negative breast cancer.

In the TROPION-Breast02 trial, DATROWAY demonstrated statistically significant and clinically meaningful improvement in OS and PFS compared with chemotherapy¹:

• mOS: 23.7 months with DATROWAY (n=323) vs 18.7 months with chemotherapy (n=321)
  • HR=0.79 (95% CI: 0.64, 0.98); P=0.0290
• mPFS: 10.8 months with DATROWAY (n=323) vs 5.6 months with chemotherapy (n=321)
  • HR=0.57 (95% CI: 0.47, 0.69); P<0.0001

OS and PFS are dual primary endpoints, per RECIST v1.1.¹

Additionally, 64% of patients responded to DATROWAY, and responses lasted ~1 year in TROPION-Breast02¹:

• ORR: 64% with DATROWAY (n=311) vs 30% with chemotherapy (n=311)
  • CR: 8% with DATROWAY vs 3% with chemotherapy
  • PR: 56% with DATROWAY vs 28% with chemotherapy
• mDoR: 11.8 months with DATROWAY (n=199; 95% CI: 9.0, 15.6) vs 7.1 months with chemotherapy (n=94; 95% CI: 5.6, 8.9)⁹
• DCR at 12 weeks: 84% with DATROWAY, 60% with chemotherapy¹⁰*

ORR, DoR, and DCR at 12 weeks are secondary endpoints.¹⁰

ORR, DoR, and DCR were not powered to show statistical differences between treatment arms. Therefore, the clinical significance of these data is not known.^1,10

See full clinical results on the Efficacy page.

*Disease control rate was defined as the percentage of patients with confirmed complete response or partial response, or who have demonstrated stable disease (per RECIST v1.1, as assessed by BICR), at 12 weeks after randomization.⁶

CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; HR, hazard ratio; mDoR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; mTNBC, metastatic triple-negative breast cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

The safety of DATROWAY was evaluated in 319 patients with triple-negative breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast02.¹

Warnings and precautions for DATROWAY include¹:

• ILD/pneumonitis
• Ocular adverse reactions
• Stomatitis
• Embryo-fetal toxicity

The most common (≥20%) adverse reactions, including laboratory abnormalities, in TROPION-Breast02 (n=319) were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased ALT, increased AST, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium, and increased blood alkaline phosphatase.¹

View the full safety profile for DATROWAY in mTNBC.

To learn more about prophylaxis and supportive regimens for select ARs, visit the AR Management page or download the Managing Select Adverse Reactions Leave Behind or Ocular Assessment Form (to be shared with optometrist or ophthalmologist to support ocular exams).

ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; ILD, interstitial lung disease; mTNBC, metastatic triple-negative breast cancer.

TROPION-Breast01 was a multicenter, open-label, randomized trial of 732 patients with unresectable or metastatic HR+, HER2− (IHC 0, IHC 1+ or IHC 2+/ISH−) breast cancer. Patients were required to have received 1 or 2 lines of prior chemotherapy in the unresectable or metastatic disease setting. Patients were randomized 1:1 to receive either DATROWAY Q3W (n=365) or chemotherapy (n=367). The major efficacy outcomes were PFS (BICR) and OS.¹

See the full study design for TROPION-Breast01.

BICR, Blinded Independent Central Review; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; mBC, metastatic breast cancer; OS, overall survival; PFS, progression-free survival; Q3W, once every 3 weeks.

In the TROPION-Breast01 trial, DATROWAY (n=365) demonstrated statistically significant mPFS and statistically insignificant mOS in comparison with chemotherapy (n=367)¹:

• mPFS: 6.9 months with DATROWAY vs 4.9 months with chemotherapy
  • HR=0.63 (95% CI: 0.52, 0.76); P<0.0001
• mOS: 18.6 months with DATROWAY vs 18.3 months with chemotherapy (HR=1.01 [95% CI: 0.83, 1.22]). Data was not statistically significant

PFS (BICR) and OS were dual primary endpoints. The study was positive if either PFS or OS results were statistically significant.^1,11

Additionally, 36% of patients responded to DATROWAY¹:

• ORR: 36% with DATROWAY (n=365) vs 23% with chemotherapy (n=367)
  • CR: 0.5% with DATROWAY
  • PR: 36% with DATROWAY vs 23% with chemotherapy
• mDoR: 6.7 months with DATROWAY (n=133; 95% CI: 5.6, 9.8) vs 5.7 months with chemotherapy (n=84; 95% CI: 4.9, 6.8)
• DCR at 12 weeks: 75% with DATROWAY, 64% with chemotherapy⁴*

ORR, DoR, and DCR were not powered to show statistical differences between treatment arms. Therefore, the clinical significance of these data is not known.^1,4

See full clinical results on the Efficacy page.

*Disease control rate at 12 weeks was defined as the percentage of patients who have a confirmed CR or PR or who have SD, per RECIST v1.1, as assessed by BICR.⁴

BICR, Blinded Independent Central Review; CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; HER2–, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; mBC, metastatic breast cancer; mDoR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR+, HER2− (IHC 0, IHC 1+ or IHC 2+/ISH−) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01.¹

Warnings and precautions for DATROWAY include¹:

• ILD/pneumonitis
• Ocular adverse reactions
• Stomatitis
• Embryo-fetal toxicity

The most common (≥20%) adverse reactions, including laboratory abnormalities, in TROPION-Breast01 (n=360) were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase.¹

View the full safety profile for DATROWAY in HR+/HER2− mBC.

Visit the AR Management page to learn more about prophylaxis and supportive regimens for select ARs.

Download the Managing Select Adverse Reactions Leave Behind and the Ocular Assessment Form (to be shared with optometrist or ophthalmologist to support ocular exams).

ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ILD, interstitial lung disease; ISH, in situ hybridization; mBC, metastatic breast cancer.

Patients in the pooled EGFRm mNSCLC analysis included those who were heavily pretreated^1,9:

• 57% of patients received 3 or more prior lines of systemic therapy in locally advanced or metastatic setting
• All patients received prior EGFR-directed therapy, including osimertinib (84%), and 99% of patients received prior platinum-based chemotherapy
• 63% of patients were female
• 70% of patients were Asian, 22% were White, and 2% were Hispanic/Latino
• A broad range of EGFR mutations were represented:
  • 53% of patients had tumors with exon 19 deletions
  • 34% had exon 21 L858R mutations
  • 28% had T790M mutations
  • 3% had exon 20 insertion mutations
  • 14% had other EGFR mutations
• 53% of patients had history of brain metastases
• 33% of patients had brain metastases at baseline
• 20% had liver metastases at baseline

See full baseline characteristics on the Study Overview page.

EGFRm, epidermal growth factor receptor-mutated; mNSCLC, metastatic non-small cell lung cancer.

The National Comprehensive Cancer Network^® (NCCN^®) has recommended datopotamab deruxtecan-dlnk (DATROWAY) as a subsequent treatment option for certain adult patients with advanced or metastatic EGFRm NSCLC regardless of EGFR mutation subtype or resistance mechanism, including^1,12:

• Exon 19 deletions, exon 21 L858R mutations, S768I mutations, L861Q mutations, G719X mutations, and exon 20 insertions

Datopotamab deruxtecan-dlnk (DATROWAY) is an NCCN Category 2A Preferred subsequent systemic therapy for patients with EGFRm nonsquamous mNSCLC, including those who^1,12:

• Received prior regimens that included EGFR-directed therapy and systemic platinum-based chemotherapy¹²
  • This may include frontline use of certain TKIs in combination with pemetrexed and cisplatin or carboplatin

Frontline treatments for advanced or metastatic EGFRm NSCLC may guide subsequent treatment decisions. Based on the datopotamab deruxtecan-dlnk (DATROWAY) Prescribing Information, there are various treatment scenarios that can determine patient eligibility in 2L or 3L+ treatment.^1,12

See the NCCN Guidelines for detailed treatment recommendations including other preferred options.

2L, second-line; 3L+, third-line or later; EGFRm, epidermal growth factor receptor-mutated; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer.

Datopotamab deruxtecan-dlnk (DATROWAY) is the only treatment to receive this designation for patients with EGFRm mNSCLC after progression on EGFR-directed therapy and platinum-based chemotherapy.^1,12

Per NCCN, Category 2A designation is based upon lower-level evidence; there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate. Preferred status is given to interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.^1,12

See the NCCN Guidelines for detailed treatment recommendations including other preferred options.

EGFRm, epidermal growth factor receptor-mutated; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer.

DATROWAY was granted Breakthrough Therapy Designation (BTD) in the US based on pooled data of patients with locally advanced or metastatic EGFRm NSCLC in both TROPION-Lung05 and TROPION-Lung01.^1,13,14

The US FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat serious conditions and address significant unmet medical needs. The FDA granted this BTD based on data from the TROPION-Lung05 phase 2 trial, along with supporting data from the TROPION-Lung01 phase 3 trial.^1,13,14

TROPION-Lung05 was a global, multicenter, single-arm, open-label trial in patients with previously treated NSCLC with an actionable genomic alteration, and TROPION-Lung01 was a global, multicenter, randomized, active-controlled, open-label trial in patients with previously treated NSCLC with or without an actionable genomic alteration. For both trials, eligible patients with EGFR-mutated NSCLC must have previously received an EGFR-directed therapy and platinum-based chemotherapy. For the pooled efficacy population, the major efficacy outcome measure was ORR by BICR. An additional efficacy outcome was DoR by BICR.¹

See the full study design for TROPION-Lung05 and TROPION-Lung01.

BICR, Blinded Independent Central Review; DoR, duration of response; EGFRm, epidermal growth factor receptor-mutated; NSCLC, non-small cell lung cancer; ORR, objective response rate.

The major efficacy outcome of DATROWAY across the pooled studies (n=114) for locally advanced or metastatic EGFRm NSCLC was an ORR of 45% (95% CI: 35, 54), with a PR of 40% and a CR of 4.4%.¹

An additional efficacy outcome of DATROWAY across the pooled studies (n=114) for locally advanced or metastatic EGFRm NSCLC was an mDoR of 6.5 months (95% CI: 4.2, 8.4).¹

See full clinical results on the Efficacy page.

CI, confidence interval; CR, complete response; EGFRm, epidermal growth factor receptor-mutated; mDoR, median duration of response; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; ORR, objective response rate; PR, partial response.

Warnings and precautions for DATROWAY include¹:

• ILD/pneumonitis
• Ocular adverse reactions
• Stomatitis
• Embryo-fetal toxicity

The pooled safety population reflects exposure to DATROWAY 6 mg/kg IV every 3 weeks in 125 patients with locally advanced or metastatic EGFRm NSCLC in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01. In this patient population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash. Serious adverse reactions occurred in 26% of patients who received DATROWAY.¹

Explore the full safety report on the Safety page.

View the full safety profile for DATROWAY in EGFRm mNSCLC.

Visit the AR Management page to learn more about prophylaxis and supportive regimens for select ARs.

Download the Managing Select Adverse Reactions Leave Behind and the Ocular Assessment Form (to be shared with optometrist or ophthalmologist to support ocular exams).

ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; EGFRm, epidermal growth factor receptor-mutated; ILD, interstitial lung disease; IV, intravenous; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer.