Overview
Entrectinib is a tropomyosin receptor tyrosine kinase (TRK) TRKA, TRKB, TRKC, proto-oncogene tyrosine-protein kinase ROS1, and anaplastic lymphoma kinase (ALK) inhibitor. It was approved by the FDA in August 2019 for use in the treatment of ROS1-positive metastatic non-small cell lung cancer and NTRK gene fusion positive solid tumors. Entrectinib's approved use is meant as a last line of therapy due to its accelerated approval based on early trial data. This therapy offers benefit over similar ALK inhibitors such as alectinib, ceritinib, and lorlatinib due to a wider range of targets.
Indication
Entrectinib is indicated for the treatment of metastatic ROS1-positive non-small cell lung cancer in adults. Entrectinib is also indicated in adults and children over 12 years old for the treatment of NTRK gene fusion-positive solid tumors which have metastasized or for which surgical resection is likely to result in severe morbidity and for which has progressed on previous therapies or for which no comparable alternative therapies are available. FoundationOne®Liquid CDx is the only FDA-approved test for the detection of ROS1 rearrangement(s) in NSCLC for selecting patients for treatment with entrectinib.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
- Metastatic Solid Neoplasm
- Solid Tumors
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/19 | N/A | Not yet recruiting | National Cancer Center, China | ||
2024/11/18 | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | ||
2024/07/30 | Phase 2 | Recruiting | |||
2024/07/01 | Phase 2 | Recruiting | |||
2024/01/08 | Phase 4 | Recruiting | |||
2023/05/17 | Phase 3 | Recruiting | |||
2023/04/28 | N/A | Completed | |||
2023/03/15 | Phase 2 | Recruiting | |||
2023/02/10 | Phase 2 | Recruiting | |||
2022/09/02 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-623 | ORAL | 50 mg in 20 1 | 2/6/2024 | |
| Genentech, Inc. | 50242-091 | ORAL | 100 mg in 1 1 | 2/6/2024 | |
| Genentech, Inc. | 50242-094 | ORAL | 200 mg in 1 1 | 2/6/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/31/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ROZLYTREK HARD CAPSULE 200MG | SIN16087P | CAPSULE | 200.00mg | 1/27/2021 | |
| ROZLYTREK HARD CAPSULE 100MG | SIN16086P | CAPSULE | 100.000mg | 1/27/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Entrectinib Capsules | 国药准字HJ20220069 | 化学药品 | 胶囊剂 | 7/26/2022 | |
| Entrectinib Capsules | 国药准字HJ20220068 | 化学药品 | 胶囊剂 | 7/26/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ROZLYTREK CAPSULES 200MG | N/A | N/A | N/A | 4/20/2020 | |
| ROZLYTREK CAPSULES 100MG | N/A | N/A | N/A | 4/20/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ROZLYTREK entrectinib 200 mg hard capsule bottle | 318002 | Medicine | A | 5/15/2020 | |
| ROZLYTREK entrectinib 100 mg hard capsule bottle | 318003 | Medicine | A | 5/15/2020 |
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