Drug profile · INN
repotrectinib
AUGTYRO
repotrectinib (AUGTYRO) is a cd74-ros1 inhibitor. Route of administration: oral. Current US regulatory status: approved.
Drug details — repotrectinib
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- ORAL
- Patents
- 19
- Programs
- 6
- Data quality
- 0.84
Quick answer
repotrectinib (AUGTYRO) is a cd74-ros1 inhibitor. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
CD74-ROS1 inhibitor
Primary target: CD74-ROS1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| PMDA | approved | — |
| NMPA | clinical trials | — |
Recent coverage
EMA Conditional Approval Pathway: Insights from Repotrectinib Oncology Approval
This article delves into the EMA Conditional Approval Pathway, highlighting key insights from the oncology approval of Repotrectinib for advanced cancer treatment.
EMA Conditional Approval Pathway: Case Study on Repotrectinib Oncology Drug
This article delves into the EMA Conditional Approval Pathway, highlighting the case study of Repotrectinib for treating ROS1-positive oncology patients.
FDA Approves Augtyro: Bristol Myers Squibb’s Repotrectinib for ROS1-NSCLC
Bristol Myers Squibb's Augtyro, a novel treatment for ROS1-positive non-small cell lung cancer, has received FDA approval, marking a significant advancement in targeted therapies.
Pipeline programs
Related & competitor drugs
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Frequently asked questions
What is repotrectinib?
repotrectinib (AUGTYRO) is a cd74-ros1 inhibitor. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for repotrectinib?
AUGTYRO is a marketed brand name for repotrectinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of repotrectinib?
repotrectinib 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.