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GEFITINIB
GEFITINIB is a Kinase Inhibitor [EPC] drug. It is currently FDA-approved (first approved 2003) for First-line treatment of metastatic NSCLC with specific EGFR mutations.
Ge fitinib is a marketed first-line treatment for metastatic NSCLC with specific EGFR mutations. Its key strength lies in its established position as an effective targeted therapy for patients with EGFR mutations. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | GEFITINIB |
|---|---|
| Drug class | Kinase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2003 |
Approved indications
- First-line treatment of metastatic NSCLC with specific EGFR mutations
Common side effects
- Skin reactions
- Diarrhea
Serious adverse events
- Respiratory failure
- Pneumonia
- Pulmonary embolism
Drug interactions
- Strong CYP3A4 Inducers (e.g., rifampicin, phenytoin, tricyclic antidepressants)
- Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole)
- Proton Pump Inhibitors
- Histamine H2-Receptor Antagonists
- Antacids
- Warfarin
Key clinical trials
- A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma (PHASE2)
- Therapy for Advanced NSCLC With EGFR 19delins Mutation (EARLY_PHASE1)
- A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases
- Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (PHASE2)
- Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
- A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) (PHASE3)
- Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (PHASE1)
- A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GEFITINIB CI brief — competitive landscape report
- GEFITINIB updates RSS · CI watch RSS
Frequently asked questions about GEFITINIB
What is GEFITINIB?
What is GEFITINIB used for?
What drug class is GEFITINIB in?
When was GEFITINIB approved?
What development phase is GEFITINIB in?
What are the side effects of GEFITINIB?
Related
- Drug class: All Kinase Inhibitor [EPC] drugs
- Indication: Drugs for First-line treatment of metastatic NSCLC with specific EGFR mutations
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing