Overview
Lorlatinib is a third-generation ALK tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer which was first approved by the US FDA in November of 2018. It was subsequently approved by the EMA in 2019 for the treatment of select patients with previously treated advanced ALK-positive non-small cell lung cancer, followed by an expanded approval in 2022 to include lorlatinib as a first-line treatment option in advanced ALK-positive NSCLC.
Indication
Lorlatinib is indicated for the treatment of adult patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). In the EU, it is indicated for the treatment of adult patients with ALK-positive advanced NSCLC not previously treated with an ALK inhibitor, or whose disease has progressed after using either alectinib or ceritinib, or crizotinib and at least one other ALK inhibitor.
Associated Conditions
- Advanced Non-Small Cell Lung Cancer (NSCLC)
- Metastatic Non-Small Cell Lung Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/25 | Phase 4 | Not yet recruiting | The First Affiliated Hospital of Guangzhou Medical University | ||
2025/03/14 | N/A | ENROLLING_BY_INVITATION | |||
2025/03/05 | Phase 3 | Not yet recruiting | |||
2024/11/15 | N/A | Not yet recruiting | Peking University Cancer Hospital & Institute | ||
2024/11/11 | Phase 2 | Not yet recruiting | |||
2024/11/07 | N/A | Not yet recruiting | |||
2024/08/01 | N/A | Recruiting | |||
2024/07/05 | Not Applicable | Recruiting | |||
2024/05/10 | N/A | Active, not recruiting | Sichuan Cancer Hospital and Research Institute | ||
2024/04/23 | Phase 2 | Recruiting |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/6/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LORVIQUA FILM-COATED TABLET 100MG | SIN15831P | TABLET, FILM COATED | 100 MG | 10/16/2019 | |
| LORVIQUA FILM-COATED TABLET 25MG | SIN15830P | TABLET, FILM COATED | 25mg | 10/16/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Lorlatinib Tablets | 国药准字HJ20220041 | 化学药品 | 片剂 | 4/27/2022 | |
| Lorlatinib Tablets | 国药准字HJ20220040 | 化学药品 | 片剂 | 4/27/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LORVIQUA lorlatinib 100 mg tablet blister pack | 310780 | Medicine | A | 11/19/2019 | |
| LORVIQUA lorlatinib 100 mg tablet bottle | 310779 | Medicine | A | 11/19/2019 | |
| LORVIQUA lorlatinib 25 mg tablet blister pack | 310778 | Medicine | A | 11/19/2019 | |
| LORVIQUA lorlatinib 25 mg tablet bottle | 310781 | Medicine | A | 11/19/2019 |
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