Overview
No overview information available.
Indication
用于ROS1阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Clinical and Scientific Monograph: Repotrectinib (AUGTYRO®)
Introduction and Overview
Repotrectinib, marketed under the brand name AUGTYRO®, represents a significant advancement in the field of precision oncology. It is a potent, orally bioavailable, small-molecule therapeutic belonging to the class of tyrosine kinase inhibitors (TKIs).[1] As a next-generation agent, Repotrectinib was specifically engineered to target key oncogenic drivers of cancer cell growth and proliferation, including the proto-oncogene tyrosine-protein kinase ROS1, the family of Tropomyosin Receptor Kinases (TRKA, TRKB, and TRKC), and Anaplastic Lymphoma Kinase (ALK).[1] Its development and subsequent approval address critical unmet medical needs in patient populations whose tumors are driven by these specific genetic alterations.
The primary clinical value of Repotrectinib stems from its rational design, which was conceived to overcome the challenge of acquired resistance—a near-universal limitation of earlier-generation TKIs. Many patients treated with first-generation inhibitors, such as crizotinib for ROS1-rearranged non-small cell lung cancer (NSCLC), eventually experience disease progression due to the emergence of secondary mutations within the kinase domain of the target protein. A predominant mechanism of such resistance is the solvent-front mutation, exemplified by the ROS1 G2032R substitution, which accounts for up to 60% of crizotinib-resistant cases.[1] The development of Repotrectinib was not merely an incremental improvement over existing therapies but a direct and strategic response to this known mechanism of clinical failure. This "resistance-first" approach to drug design signifies a paradigm shift, where the molecular basis of treatment failure informs the foundational chemistry of the next therapeutic agent.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/13 | Phase 2 | Recruiting | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | ||
2024/07/10 | Phase 1 | Completed | |||
2024/05/10 | Phase 2 | Recruiting | |||
2024/04/08 | Phase 1 | Completed | |||
2024/03/18 | Phase 2 | Recruiting | MedSIR | ||
2023/11/20 | Phase 3 | Active, not recruiting | |||
2023/07/03 | N/A | AVAILABLE | |||
2024/11/27 | Phase 1 | Completed | |||
2023/04/25 | Phase 1 | Withdrawn | |||
2021/10/08 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| E.R. Squibb & Sons, L.L.C. | 0003-4040 | ORAL | 40 mg in 1 1 | 11/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/13/2025 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AUGTYRO CAPSULES 40MG | N/A | N/A | N/A | 2/19/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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