Prescription medicine
Datopotamab deruxtecan Brand names: Datroway
Datopotamab deruxtecan (Datroway) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the datopotamab deruxtecan FDA label on DailyMed (effective May 27, 2026); every datopotamab deruxtecan label on DailyMed.
Highlights of the record
FDA label of May 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
Forms and strengths
- 100 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 639 through July 30, 2026
What is datopotamab deruxtecan used for?
From the label: indications and usageDATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ]. […]
Conditions named in the indications of datopotamab deruxtecan's FDA labels, with every medicine labeled for each:
From other datopotamab deruxtecan labelsLung cancer: Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer …
Breast cancer: Cancer (TNBC) DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ].
Source: FDA drug label (DATROWAY), Daiichi Sankyo Inc., effective May 27, 2026 (SPL set 2950227c-6230-4ca4-a135-46e44d9424a0), via openFDA; the full label on DailyMed
What does the patient leaflet for datopotamab deruxtecan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DATROWAY?DATROWAY can cause serious side effects, including: Lung problems that may be severe, life-threatening, or that may lead to death. If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms: cough trouble breathing or shortness of breath fever other new or worsening breathing symptoms such as chest tightness or wheezing Eye problems. Eye problems are common with DATROWAY and can also be severe. Tell your healthcare provider right away if you develop any new or worsening eye problems during treatment with DATROWAY, including dry eyes, eye pain, eye redness, eye swelling, eye irritation, increased tears, feeling like something is in your eyes, discharge from your eyes, eye crusting, sensitivity to light, blurred vision, or vision changes. You should use preservative-free lubricating eye drops at least 4 times a day and as needed. Do not wear contact lenses during treatment with DATROWAY unless your eye specialist tells you to. Your healthcare provider will send you to an eye specialist to check your eyes when you start your treatment with DATROWAY, every three 21-day treatment cycles (about every 9 weeks), at the end of treatment, and as needed for any new or worsening signs and symptoms of eye problems. Mouth ulcers and sores. Mouth ulcers and sores are common with DATROWAY and can also be severe. Tell your healthcare provider right away if you develop mouth pain, swelling, redness, ulcers, or sores during treatment with DATROWAY. Your healthcare provider will prescribe a steroid-containing mouthwash to use 4 times a day and as needed during treatment with DATROWAY. […]
Source: FDA drug label (DATROWAY), Daiichi Sankyo Inc., effective May 27, 2026 (SPL set 2950227c-6230-4ca4-a135-46e44d9424a0), via openFDA; the full label on DailyMed
Is there a generic for datopotamab deruxtecan (Datroway)?
No generic datopotamab deruxtecan is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the datopotamab deruxtecan label say about other medicines?
The datopotamab deruxtecan label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorescein | warnings and precautions | Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, at end of treatment, and as clinically indicated. |
| Prednisolone | warnings and precautions | For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). |
Source: FDA drug label (DATROWAY), Daiichi Sankyo Inc., effective May 27, 2026 (SPL set 2950227c-6230-4ca4-a135-46e44d9424a0), via openFDA; the full label on DailyMed
What do FAERS reports show for datopotamab deruxtecan?
The FDA Adverse Event Reporting System holds 639 reports that list datopotamab deruxtecan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 138 are coded as a death and 115 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as datopotamab deruxtecan?
20 other medicines are given the same way (intravenous) and in the same FDA class as datopotamab deruxtecan or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Docetaxel | Breast cancer, Lung cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer, Lung cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer, Lung cancer | 10 labelers | n/a | No current entry |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as datopotamab deruxtecan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to datopotamab deruxtecan
- 20 medicines for the same use
- Datopotamab deruxtecan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other