Drug profile · INN
datopotamab deruxtecan-dlnk
DATROWAY
datopotamab deruxtecan-dlnk (DATROWAY) is an FDA-listed pharmaceutical active ingredient. Route of administration: iv (infusion). Current US regulatory status: approved.
Drug details — datopotamab deruxtecan-dlnk
- US status
- approved
- Class
- —
- Route
- IV (INFUSION)
- Patents
- 0
- Programs
- 6
- Data quality
- 0.84
Quick answer
datopotamab deruxtecan-dlnk (DATROWAY) is an FDA-listed pharmaceutical active ingredient. Route of administration: iv (infusion). Current US regulatory status: approved.
Key facts
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
Recent coverage
EMA backs datopotamab deruxtecan, but lung cancer access remains unclear
EMA recommended datopotamab deruxtecan in Europe, but the supported EU approval in the evidence base is for HR-positive, HER2-negative breast cancer rather than lung cancer. In the U.S., DATROWAY has accelerated approval for EGFR-mutated NSCLC, making this a key catalyst-tracking update for BD teams and investors.
EMA backs datopotamab deruxtecan for advanced lung cancer
EMA action on datopotamab deruxtecan adds a key catalyst for lung cancer tracking, even as the program’s regulatory path differs by region. For BD teams, investors, and analysts, the story now centers on approval status, label scope, and the next clinical and filing milestones.
Datroway Approved: A New Hope for Metastatic TNBC Patients
The FDA has approved Datroway, the first TROP2-directed antibody drug conjugate, for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC). This landmark approval offers a new therapeutic avenue for a challenging patient population.
Datroway Priority Review Fuels Hope for Metastatic Triple-Negative Breast Cancer Patients
The FDA has granted Priority Review to Datroway for the treatment of metastatic triple-negative breast cancer (TNBC) in patients not eligible for immunotherapy. This designation marks a significant step for AstraZeneca and offers a potential new therapeutic avenue for a challenging cancer subtype.
Pipeline programs
Frequently asked questions
What is datopotamab deruxtecan-dlnk?
datopotamab deruxtecan-dlnk (DATROWAY) is an FDA-listed pharmaceutical active ingredient. Route of administration: iv (infusion). Current US regulatory status: approved.
What is the brand name for datopotamab deruxtecan-dlnk?
DATROWAY is a marketed brand name for datopotamab deruxtecan-dlnk. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of datopotamab deruxtecan-dlnk?
datopotamab deruxtecan-dlnk has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.