CLINICAL TRIALS PROFILE FOR GEFITINIB

505(b)(2) Clinical Trials for gefitinib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02353741 ↗	Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC	Terminated	Xinqiao Hospital of Chongqing	Phase 2	2015-04-01	This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.

All Clinical Trials for gefitinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005806 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
NCT00005806 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
NCT00006048 ↗	ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer	Unknown status	AstraZeneca	Phase 3	2000-05-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
NCT00006049 ↗	ZD 1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer	Unknown status	AstraZeneca	Phase 3	2000-05-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage III or stage IV non-small cell lung cancer.
NCT00012337 ↗	ZD 1839 in Treating Patients With Metastatic Kidney Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-01-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to die. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have metastatic kidney cancer.

Clinical Trial Conditions for gefitinib

Condition Name

Condition Name for gefitinib
Intervention	Trials
Non-Small Cell Lung Cancer	57
Lung Cancer	40
Non Small Cell Lung Cancer	24
Carcinoma, Non-Small-Cell Lung	19

Condition MeSH

Condition MeSH for gefitinib
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	204
Lung Neoplasms	172
Adenocarcinoma	29
Carcinoma	25

Clinical Trial Locations for gefitinib

Trials by Country

Trials by Country for gefitinib
Location	Trials
United States	517
China	169
Japan	92
Korea, Republic of	90
Italy	88

Trials by US State

Trials by US State for gefitinib
Location	Trials
New York	40
Texas	33
California	30
Massachusetts	28
Pennsylvania	24

Clinical Trial Progress for gefitinib

Clinical Trial Phase

Clinical Trial Phase for gefitinib
Clinical Trial Phase	Trials
PHASE2	3
Phase 4	11
Phase 3	53

Clinical Trial Status

Clinical Trial Status for gefitinib
Clinical Trial Phase	Trials
Completed	202
Unknown status	76
Terminated	36

Clinical Trial Sponsors for gefitinib

Sponsor Name

Sponsor Name for gefitinib
Sponsor	Trials
AstraZeneca	92
National Cancer Institute (NCI)	65
Sun Yat-sen University	14

Sponsor Type

Sponsor Type for gefitinib
Sponsor	Trials
Other	429
Industry	200
NIH	68

Gefitinib Clinical Trials Update, Market Outlook, and Patent-Driven Generic/Biosimilar Risk

Last updated: May 25, 2026

Gefitinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor used in non-small cell lung cancer (NSCLC) and, in some jurisdictions, other EGFR-driven indications. Market dynamics are dominated by: (1) uptake in EGFR-mutated NSCLC with guideline-concordant sequencing, (2) competitive displacement by newer EGFR inhibitors, and (3) country-level pricing and reimbursement pressures. A current patent-and-regulatory view is required to map near-term generic entry risk, but that specific estate and Orange Book status cannot be compiled from the information available in this session, so a litigation-ready projection is not produced here.

What is the current clinical-trials status of gefitinib in NSCLC?

Answer: Gefitinib’s trial footprint remains concentrated in EGFR-mutated NSCLC, with ongoing or recently updated studies typically focusing on: first-line versus comparator EGFR inhibitors, combination regimens (chemo or anti-angiogenic agents), and real-world post-marketing evidence rather than new pivotal development.

What trial designs are most common for gefitinib now?

• Randomized comparative studies in EGFR-mutated advanced NSCLC (often against newer TKIs).
• Combination studies testing gefitinib plus chemotherapy or targeted agents in selected molecular subgroups.
• Biomarker-stratified designs using EGFR mutation status (exon 19 deletion, L858R), resistance markers, and line-of-therapy stratification.

How do gefitinib trial endpoints typically translate to uptake?

• Progression-free survival (PFS) and overall survival (OS) drive guideline inclusion and formulary decisions.
• Safety tolerability informs sequencing decisions versus second/third-generation EGFR inhibitors.
• Biomarker response rates impact reimbursement in regions that restrict EGFR TKIs by mutation and line.

How do recent trials place gefitinib versus osimertinib, erlotinib, and other EGFR TKIs?

Answer: Gefitinib’s competitive position is weaker in first-line settings where osimertinib has become preferred in EGFR-mutated NSCLC, with gefitinib more often retained in settings where access, cost, or molecular eligibility favors earlier-generation TKIs.

What is the practical competitive outcome for gefitinib?

• In markets adopting osimertinib-centric pathways, gefitinib use shifts toward later lines, limited-access environments, or scenarios where clinicians prefer earlier-generation TKIs.
• Where second-generation EGFR inhibitors gain traction (or where payer restrictions apply), gefitinib faces harder comparative benchmarks on efficacy and durability.

What is the gefitinib market size and growth outlook by region?

Answer: Geographically, gefitinib demand is shaped by three forces: (1) EGFR testing penetration, (2) reimbursement rules for EGFR TKIs, and (3) pricing pressure from generics. Growth tends to be modest relative to high-growth oncology classes because competitive displacement by newer inhibitors caps incremental demand.

How do reimbursement and pricing typically drive gefitinib revenue?

• Patent cliff and generic penetration reduce unit price and can reduce value even when volume holds.
• Payer preferences for specific TKIs in treatment pathways can shift prescribing away from gefitinib.

What is the likely region-by-region pattern?

• Higher sensitivity to generic entry in established generics markets.
• Greater resistance to displacement where clinicians rely on older TKIs due to formulary constraints.
• Reimbursement in some regions can remain tied to measurable EGFR mutation status, sustaining baseline volume.

When does gefitinib lose exclusivity, and how does that affect generic entry?

Answer: A precise exclusivity timeline requires the drug’s jurisdiction-specific Orange Book and patent list, which cannot be compiled from the available information in this session. As a result, no launch-year-specific generic forecast is provided here.

What generic entry risk exists for gefitinib?

• Generics can enter once patents and exclusivity tied to the reference product expire, or via Paragraph IV challenges where applicable.
• Even if base-product exclusivity ends, secondary patents on formulations, manufacturing methods, and use can extend barriers in certain markets.

What patents protect gefitinib and what formulations are covered?

Answer: A complete patent landscape is not produced here because compiling the protection set requires jurisdiction-specific patent and Orange Book data that is not available in the session.

What patent types usually matter for gefitinib?

• Active ingredient polymorph and crystalline form claims.
• Pharmaceutical composition claims (excipients, dosage forms).
• Manufacturing process claims.
• Method-of-use claims tied to EGFR mutation subgroups or dosing regimens.

What is the FDA status of gefitinib, and is it eligible for generic substitution?

Answer: Gefitinib is an FDA-regulated small-molecule anticancer drug with a history of approval for NSCLC. However, an Orange Book status determination and current generic substitution risk require Orange Book listings for the specific NDA and strength, which cannot be verified from the information available here. No specific FDA pathway assertions are included.

How strong is gefitinib’s competitive moat against newer EGFR inhibitors?

Answer: The moat is mostly economic and access-driven rather than clinical differentiation in modern EGFR-algorithm treatment sequences.

What determines continued prescribing for gefitinib?

• Cost advantage versus newer agents after generic entry.
• Formulary inclusion in health systems that restrict high-cost TKIs.
• Availability and clinician familiarity.
• Specific patient or line-of-therapy contexts where newer inhibitors are not accessible.

What clinical evidence would most likely expand or shrink gefitinib use?

Answer: Expansion hinges on clear comparative benefits in defined molecular subsets and/or improved safety in real-world sequencing. Shrinkage occurs when randomized data and guideline updates establish superior efficacy or better tolerability for alternative agents that become the default first-line choice.

Key evidence categories

• Head-to-head or regimen-sequencing comparisons with modern EGFR standards.
• Head-to-head tolerability and dose-modification profiles.
• Resistance-mechanism stratification that improves subsequent line outcomes.

Gefitinib market projection scenarios: baseline, downside, and upside

Answer: A quantified multi-year projection is not provided because a defensible forecast requires current sales baselines (units and revenue), generic penetration by geography, and patent expiry sequencing. Those inputs are not available in this session.

Scenario drivers that would be used in a quantified model

• Generic entry timing by major markets.
• Share shift due to guideline adoption of osimertinib or other newer agents.
• EGFR testing rates and age-of-population oncology incidence.
• Pricing trajectories post-generic entry.
• Evidence-based sequencing effects (first-line versus later lines).

Key Takeaways

• Gefitinib’s clinical development presence is primarily EGFR-mutated NSCLC and combination/biomarker stratification rather than new late-stage breakthroughs.
• Market demand is increasingly governed by treatment-pathway sequencing and payer-driven molecule selection, with generic competition and price compression defining most revenue movement.
• Patent exclusivity, Orange Book listings, and Paragraph IV litigation status cannot be mapped from the available information in this session, so no launch-year-specific generic or litigation-driven forecast is provided.

FAQs

1. Is gefitinib still recommended for first-line EGFR-mutated NSCLC in 2026?
2. What EGFR mutations predict response to gefitinib and how do resistance markers change outcomes?
3. How does gefitinib toxicity profile compare with osimertinib and erlotinib for real-world dosing?
4. What formulation factors affect bioavailability and switching risk between gefitinib generics?
5. Which countries show the highest likelihood of gefitinib generics replacing branded supply fastest?

References

1. European Medicines Agency (EMA). Gefitinib product information and assessment history.
2. U.S. Food and Drug Administration (FDA). Drug approvals and labeling history for gefitinib.
3. NCCN Clinical Practice Guidelines in Oncology (NSCLC). EGFR-mutated treatment pathway updates.
4. ClinicalTrials.gov. Gefitinib interventional and observational trial listings.