Overview
Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.
Background
Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.
Indication
For the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of either platinum-based or docetaxel chemotherapies.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/10/08 | Phase 2 | Recruiting | |||
2024/09/19 | N/A | Recruiting | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
2023/04/28 | N/A | Completed | |||
2020/10/05 | N/A | UNKNOWN | |||
2020/06/11 | Phase 2 | UNKNOWN | |||
2020/04/24 | Phase 2 | UNKNOWN | Second Affiliated Hospital of Nanchang University | ||
2020/01/30 | Phase 3 | Active, not recruiting | |||
2020/01/27 | Phase 3 | UNKNOWN | |||
2019/11/27 | N/A | Completed | |||
2019/10/29 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Qilu Pharmaceutical Co., Ltd. | 67184-0531 | ORAL | 250 mg in 1 1 | 2/22/2023 | |
Apotex Corp. | 60505-4512 | ORAL | 250 mg in 1 1 | 8/20/2023 | |
Natco Pharma USA LLC | 69339-168 | ORAL | 250 mg in 1 1 | 9/27/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-0482 | ORAL | 250 mg in 1 1 | 2/28/2023 | |
Teva Pharmaceuticals, Inc. | 0480-4053 | ORAL | 250 mg in 1 1 | 6/21/2023 | |
Ingenus Pharmaceuticals, LLC | 50742-366 | ORAL | 250 mg in 1 1 | 4/27/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Withdrawn | 9/27/2018 | ||
Authorised | 6/24/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
IRESSA TABLET 250 mg | SIN12300P | TABLET, FILM COATED | 250 mg | 5/22/2003 | |
GEFTINAT FILM COATED TABLETS 250 MG | SIN16130P | TABLET, FILM COATED | 250.00 mg | 3/22/2021 | |
INGEFITINIB FILM COATED TABLET 250MG | SIN16055P | TABLET, FILM COATED | 250.00 mg | 12/4/2020 | |
HOVID GEFITINIB TABLETS 250 MG | SIN15984P | TABLET, FILM COATED | 250 mg | 8/4/2020 | |
VEIASU FILM-COATED TABLETS 250 MG | SIN16030P | TABLET, FILM COATED | 250.00 mg | 10/22/2020 | |
GEFITINIB-TEVA FC TABLET 250MG | SIN16722P | TABLET, FILM COATED | 250 mg | 3/2/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Gefitinib Tablets | 国药准字HJ20230142 | 化学药品 | 片剂 | 12/5/2023 | |
Gefitinib Tablets | 国药准字H20203219 | 化学药品 | 片剂 | 5/26/2020 | |
Gefitinib Tablets | 国药准字H20203215 | 化学药品 | 片剂 | 5/26/2020 | |
Gefitinib Tablets | 国药准字H20213551 | 化学药品 | 片剂 | 6/29/2021 | |
Gefitinib Tablets | 国药准字HJ20181042 | 化学药品 | 片剂 | 5/6/2022 | |
Gefitinib Tablets | 国药准字H20203704 | 化学药品 | 片剂 | 12/25/2020 | |
Gefitinib Tablets | 国药准字H20223589 | 化学药品 | 片剂 | 8/10/2022 | |
Gefitinib Tablets | 国药准字H20243617 | 化学药品 | 片剂 | 4/24/2024 | |
Gefitinib Tablets | 国药准字H20193362 | 化学药品 | 片剂 | 8/7/2024 | |
Gefitinib Tablets | 国药准字H20163465 | 化学药品 | 片剂 | 8/31/2021 |
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 |
---|---|---|---|---|---|
GEFITINIB APOTEX gefitinib 250 mg film coated tablet blister pack | 301162 | Medicine | A | 2/14/2019 | |
GEFTICIP gefitinib 250 mg tablet blister pack | 318432 | Medicine | A | 5/6/2020 | |
GEFTIRESS gefitinib 250 mg tablet blister pack | 318355 | Medicine | A | 5/6/2020 | |
GEFITINIB APOTEX gefitinib 250 mg film coated tablet bottle | 301163 | Medicine | A | 2/14/2019 | |
APO-GEFITINIB gefitinib 250 mg film coated tablet blister pack | 301161 | Medicine | A | 2/14/2019 | |
IRESSA gefitinib 250 mg tablet blister pack | 90010 | Medicine | A | 4/28/2003 | |
APO-GEFITINIB gefitinib 250 mg film coated tablet bottle | 301160 | Medicine | A | 2/14/2019 | |
CIPLA GEFITINIB gefitinib 250 mg tablet blister pack | 318433 | Medicine | A | 5/6/2020 |