Overview
Brigatinib, originally named AP26113, is a reversible dual inhibitor of anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR). It presents selectivity against the mutant forms of EGFR compared to the wild-type. It also exhibits selectivity against 9 different Crizotinib-resistant mutants of the EML4-ALK fusion gene, which is a pivotal player in the transformation of susceptible lung parenchyma. Brigatinib was developed by Ariad Pharmaceuticals, a subsidiary of Takeda Pharmaceutical Company Limited, and FDA-approved on April 28, 2017.
Indication
The anaplastic lymphoma kinase positive, metastatic non-small cell lung cancer (ALK+ NSCLC), represents only 3-5% of the NSCLC cancer cases, but the ALK mutation, overexpression and presence in several oncogenic fusion proteins in solid and hematologic tumors have pointed out the importance as well as its potential as a cancer therapy target. The ALK-related cases of NSCLC are associated with the presence of the fusion gene EML4-ALK which fused the ALK protein with the echinoderm microtubule-associated protein like-4 whose original function is the correct formation of microtubules. The presence of the aberrant fusion protein results in abnormal signaling that provokes increased cell growth, proliferation and survival. Crizotinib is indicated for the treatment of such cases but the presence of ALK kinase domain mutations confer resistance to the treatment. Thus, brigatinib is indicated for the treatment of patients with ALK+ NSCLC with intolerance to Crizotinib.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/06 | Phase 2 | Not yet recruiting | |||
2024/08/01 | N/A | Recruiting | |||
2024/07/26 | Phase 2 | Withdrawn | |||
2023/11/15 | Phase 1 | Completed | |||
2023/04/28 | N/A | Completed | |||
2023/02/10 | N/A | Active, not recruiting | |||
2023/02/08 | Phase 2 | Withdrawn | |||
2022/05/04 | Phase 2 | UNKNOWN | |||
2022/01/20 | Phase 2 | Active, not recruiting | Intergroupe Francophone de Cancerologie Thoracique | ||
2021/10/29 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 63020-090 | ORAL | 90 mg in 1 1 | 2/1/2022 | |
| Takeda Pharmaceuticals America, Inc. | 63020-113 | ORAL | 30 mg in 1 1 | 2/1/2022 | |
| Takeda Pharmaceuticals America, Inc. | 63020-180 | ORAL | 180 mg in 1 1 | 2/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/22/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ALUNBRIG FILM-COATED TABLET 30mg | SIN15658P | TABLET, FILM COATED | 30mg | 4/4/2019 | |
| ALUNBRIG FILM-COATED TABLET 90mg | SIN15659P | TABLET, FILM COATED | 90mg | 4/4/2019 | |
| ALUNBRIG FILM-COATED TABLET 180mg | SIN15660P | TABLET, FILM COATED | 180mg | 4/4/2019 | |
| ALUNBRIG INITIATION PACK | SIN15661P | TABLET, FILM COATED | 180.00mg | 4/4/2019 | |
| ALUNBRIG INITIATION PACK | SIN15661P | TABLET, FILM COATED | 90mg | 4/4/2019 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ALUNBRIG brigatinib 90 mg and 180 mg film-coated tablets blister pack | 299966 | Medicine | A | 3/6/2019 | |
| ALUNBRIG brigatinib 90 mg film-coated tablet blister pack | 299968 | Medicine | A | 3/6/2019 | |
| ALUNBRIG brigatinib 30 mg film-coated tablet blister pack | 299965 | Medicine | A | 3/6/2019 | |
| ALUNBRIG brigatinib 180 mg film-coated tablet blister pack | 299964 | Medicine | A | 3/6/2019 | |
| ALUNBRIG brigatinib 180 mg film-coated tablet bottle | 299967 | Medicine | A | 3/6/2019 | |
| ALUNBRIG brigatinib 30 mg film-coated tablet bottle | 299962 | Medicine | A | 3/6/2019 | |
| ALUNBRIG brigatinib 90 mg film-coated tablet bottle | 299963 | Medicine | A | 3/6/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ALUNBRIG | takeda canada inc | 02479230 | Tablet
,
Kit - Oral | 180 MG | 8/31/2018 |
| ALUNBRIG | takeda canada inc | 02479230 | Tablet
,
Kit - Oral | 90 MG | 8/31/2018 |
| ALUNBRIG | takeda canada inc | 02479214 | Tablet - Oral | 90 MG | 8/31/2018 |
| ALUNBRIG | takeda canada inc | 02479222 | Tablet - Oral | 180 MG | 8/31/2018 |
| ALUNBRIG | takeda canada inc | 02479206 | Tablet - Oral | 30 MG | 8/31/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ALUNBRIG 90MG + 180MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1181264012 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| ALUNBRIG 30 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1181264011 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| ALUNBRIG 90 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1181264008 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| ALUNBRIG 180 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1181264010 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
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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