Overview
Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif . For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test . Gilotrif (afatinib) is the first FDA-approved oncology product from Boehringer Ingelheim .
Indication
Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test , and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy . Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim's Gilotrif (afatinib) for the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test . The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I .
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
- Refractory, metastatic squamous cell Non-small cell lung cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Recruiting | |||
2025/06/08 | Phase 1 | Recruiting | |||
2025/02/03 | Phase 2 | Recruiting | |||
2025/01/06 | Phase 3 | ENROLLING_BY_INVITATION | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | ||
2024/12/19 | Phase 1 | Recruiting | |||
2024/11/28 | Phase 2 | Not yet recruiting | |||
2024/10/18 | Phase 1 | Recruiting | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||
2024/07/10 | Phase 1 | Recruiting | |||
2024/04/26 | Phase 2 | Active, not recruiting | |||
2024/03/12 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0141 | ORAL | 20 mg in 1 1 | 4/13/2022 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0138 | ORAL | 40 mg in 1 1 | 4/13/2022 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0137 | ORAL | 30 mg in 1 1 | 4/13/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/25/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GIOTRIF FILM-COATED TABLETS 50MG | SIN14463P | TABLET, FILM COATED | 50.0000mg | 12/17/2013 | |
| GIOTRIF FILM-COATED TABLETS 20MG | SIN14460P | TABLET, FILM COATED | 20.0000mg | 12/17/2013 | |
| GIOTRIF FILM-COATED TABLETS 30MG | SIN14461P | TABLET, FILM COATED | 30.0000mg | 12/17/2013 | |
| GIOTRIF FILM-COATED TABLETS 40MG | SIN14462P | TABLET, FILM COATED | 40.0000mg | 12/17/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Afatinib Dimaleate Tablets | 国药准字H20203716 | 化学药品 | 片剂 | 12/25/2020 | |
| Afatinib Dimaleate Tablets | 国药准字H20203233 | 化学药品 | 片剂 | 6/2/2020 | |
| Afatinib Dimaleate Tablets | 国药准字H20213349 | 化学药品 | 片剂 | 5/11/2021 | |
| Afatinib Dimaleate Tablets | 国药准字HJ20170071 | 化学药品 | 片剂 | 7/12/2021 | |
| Afatinib Dimaleate Tablets | 国药准字H20249202 | 化学药品 | 片剂 | 10/29/2024 | |
| Afatinib Dimaleate Tablets | 国药准字H20213523 | 化学药品 | 片剂 | 6/18/2021 | |
| Afatinib Dimaleate Tablets | 国药准字H20213526 | 化学药品 | 片剂 | 6/18/2021 | |
| Afatinib Dimaleate Tablets | 国药准字HJ20170067 | 化学药品 | 片剂 | 7/12/2021 | |
| Afatinib Dimaleate Tablets | 国药准字H20203230 | 化学药品 | 片剂 | 6/2/2020 | |
| Afatinib Dimaleate Tablets | 国药准字H20234061 | 化学药品 | 片剂 | 8/29/2023 |
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 |
|---|---|---|---|---|---|
| GIOTRIF afatinib 50 mg (as dimaleate) film coated tablet blister pack | 201320 | Medicine | A | 11/7/2013 | |
| GIOTRIF afatinib 20 mg (as dimaleate) film coated tablet blister pack | 201314 | Medicine | A | 11/7/2013 | |
| GIOTRIF afatinib 30 mg (as dimaleate) film coated tablet blister pack | 201318 | Medicine | A | 11/7/2013 | |
| GIOTRIF afatinib 40 mg (as dimaleate) film coated tablet blister pack | 201315 | Medicine | A | 11/7/2013 |
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