Overview
Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability. Approved under accelerated approval in 2015, alectinib is indicated for use in patients who have progressed on or were not tolerant of crizotinib, which is associated with the development of resistance.
Indication
Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Associated Conditions
- Refractory, metastatic Non small cell lung cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/03 | Phase 1 | Not yet recruiting | |||
2025/03/06 | N/A | Recruiting | |||
2025/01/09 | Phase 3 | Recruiting | |||
2024/11/29 | Not Applicable | Not yet recruiting | |||
2024/11/18 | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | ||
2024/10/02 | Phase 3 | Recruiting | |||
2024/08/01 | N/A | Recruiting | |||
2024/04/09 | Phase 1 | Active, not recruiting | |||
2024/04/01 | N/A | Completed | |||
2023/08/14 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-130 | ORAL | 150 mg in 1 1 | 6/16/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/16/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ALECENSA HARD CAPSULE 150MG | SIN15220P | CAPSULE | 150 mg | 4/24/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Alectinib Hydrochloride Capsules | 国药准字HJ20180047 | 化学药品 | 胶囊剂 | 1/10/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ALECENSA CAPSULES 150MG | N/A | N/A | N/A | 12/9/2016 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ALECENSA alectinib hydrochloride 150 mg hard capsule blister pack | 272115 | Medicine | A | 3/14/2017 |
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