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Iressa (gefitinib)
Iressa (generic name: gefitinib) is a Kinase Inhibitor [EPC] drug developed by Pfizer Inc.. It is currently FDA-approved (first approved 2003) for Non-small cell lung cancer, Non-small cell lung cancer, positive for epidermal growth factor receptor expression.
Iressa blocks the epidermal growth factor receptor (EGFR) signaling pathway, preventing cancer cell growth and proliferation.
Iressa (gefitinib) is a small molecule kinase inhibitor developed by AstraZeneca, targeting the epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC) cells. It was FDA-approved in 2003 for treating NSCLC with EGFR expression. Iressa is now off-patent, with multiple generic manufacturers available. Key safety considerations include potential liver toxicity and skin rash. As a kinase inhibitor, Iressa blocks the EGFR signaling pathway, preventing cancer cell growth and proliferation.
At a glance
| Generic name | gefitinib |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Epidermal growth factor receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2003 |
Mechanism of action
The epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells and plays role in the processes of cell growth and proliferation. Some EGFR activating mutations (exon 19 deletion or exon 21 point mutation L858R) within NSCLC cells have been identified as contributing to the promotion of tumor cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.Gefitinib reversibly inhibits the kinase activity of wild-type and certain activating mutations of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor, thereby inhibiting further downstream signaling and blocking EGFR-dependent proliferation.Gefitinib binding affinity for EGFR exon 19 deletion or exon 21 point mutation L858R mutations is higher than its affinity for the wild-type EGFR. Gefitinib also inhibits IGF and PDGF-mediated signaling at clinically relevant con
Approved indications
- Non-small cell lung cancer
- Non-small cell lung cancer, positive for epidermal growth factor receptor expression
Common side effects
- Skin reactions
- Diarrhea
- Nail disorders
- Decreased appetite
- Vomiting
- Stomatitis
- Conjunctivitis/blepharitis/dry eye
- Alanine aminotransferase Increase
- Aspartate aminotransferase Increased
- Proteinuria
- Nausea
- Pneumonia
Drug interactions
- carbamazepine
- dexamethasone
- fosphenytoin
- phenobarbital
- phenytoin
- primidone
- rifabutin
- rifampicin
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:
- Iressa CI brief — competitive landscape report
- Iressa updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Iressa
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Related
- Drug class: All Kinase Inhibitor [EPC] drugs
- Target: All drugs targeting Epidermal growth factor receptor
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Non-small cell lung cancer, positive for epidermal growth factor receptor expression
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing