Vizimpro: Uses, Dosage & Side Effects
An irreversible pan-HER tyrosine kinase inhibitor for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations
Vizimpro (dacomitinib) is a second-generation, irreversible pan-HER tyrosine kinase inhibitor used as first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating epidermal growth factor receptor (EGFR) mutations. It is taken orally as a once-daily tablet at a recommended starting dose of 45 mg. In the pivotal ARCHER 1050 clinical trial, Vizimpro demonstrated superior progression-free survival and overall survival compared to gefitinib, establishing it as an effective treatment option for EGFR-mutated advanced NSCLC. Vizimpro is manufactured by Pfizer and requires a prescription.
Quick Facts: Vizimpro
Key Takeaways
- Vizimpro (dacomitinib) is a second-generation, irreversible EGFR tyrosine kinase inhibitor approved as first-line monotherapy for metastatic NSCLC with activating EGFR exon 19 deletion or exon 21 L858R mutations.
- In the ARCHER 1050 trial, Vizimpro demonstrated superior progression-free survival (14.7 vs 9.2 months) and overall survival (34.1 vs 26.8 months) compared to gefitinib, making it one of the most effective first-line EGFR TKIs.
- Diarrhea, skin rash, and stomatitis are the most common side effects and should be managed proactively; dose reductions to 30 mg or 15 mg are available to maintain treatment tolerability.
- Proton pump inhibitors (PPIs) must not be taken concurrently as they reduce Vizimpro absorption; H2 blockers may be used with appropriate timing separation (2 hours before or 10 hours after).
- Women of childbearing potential must use effective contraception during treatment and for at least 17 days after the final dose; Vizimpro must not be used during pregnancy or breastfeeding.
What Is Vizimpro and What Is It Used For?
Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors. These medications work by blocking specific enzymes known as tyrosine kinases that are essential for cancer cell growth and survival. Dacomitinib is classified as a second-generation EGFR inhibitor because, unlike first-generation agents such as erlotinib and gefitinib, it forms an irreversible (permanent) bond with its target receptor. This irreversible binding means that once dacomitinib attaches to the receptor, the receptor remains blocked until the cell produces a new one, providing more sustained and complete inhibition of the cancer-driving signaling pathway.
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 80–85% of all lung cancer cases worldwide. In a significant subset of NSCLC patients—approximately 10–15% of Caucasian patients and 30–50% of Asian patients—the cancer is driven by specific activating mutations in the epidermal growth factor receptor (EGFR) gene. The two most common activating mutations are exon 19 deletions (accounting for roughly 45% of EGFR mutations) and the L858R point mutation in exon 21 (approximately 40% of EGFR mutations). These mutations cause the EGFR protein to be constantly switched on, sending continuous growth signals that drive cancer cell proliferation, survival, and spread. Vizimpro specifically targets and blocks this abnormal signaling.
As a pan-HER inhibitor, Vizimpro does not only block EGFR (also known as HER1 or ErbB1), but also inhibits HER2 (ErbB2) and HER4 (ErbB4). This broader spectrum of inhibition may provide additional therapeutic benefit by preventing compensatory signaling through related receptor pathways that cancer cells sometimes exploit to escape targeted therapy. By covalently (irreversibly) binding to the intracellular kinase domains of these receptors, dacomitinib prevents the autophosphorylation events that initiate downstream signaling cascades, including the RAS/RAF/MEK/ERK and PI3K/AKT/mTOR pathways—both of which are critical regulators of cell proliferation, survival, migration, and angiogenesis.
Vizimpro is approved for use as first-line treatment when the cancer has spread (metastasized) to the other lung or to other organs. Before starting treatment, a laboratory test must confirm that the tumor carries one of the qualifying EGFR mutations (exon 19 deletion or exon 21 L858R substitution). This testing is typically performed on a tumor biopsy sample using validated molecular diagnostic methods, or increasingly through liquid biopsy (circulating tumor DNA analysis from a blood sample). The presence of an activating EGFR mutation means the cancer is likely to respond well to EGFR-targeted therapy with Vizimpro.
The approval of Vizimpro was based primarily on the results of the ARCHER 1050 clinical trial, a landmark phase III randomized study that compared dacomitinib with gefitinib (a first-generation EGFR TKI) as first-line therapy in 452 patients with advanced NSCLC harboring EGFR-activating mutations. The trial demonstrated that Vizimpro significantly improved progression-free survival (PFS), with a median PFS of 14.7 months for dacomitinib compared to 9.2 months for gefitinib (hazard ratio 0.59). Notably, updated overall survival (OS) data showed a median OS of 34.1 months for dacomitinib versus 26.8 months for gefitinib (hazard ratio 0.76), representing one of the first demonstrations of an overall survival advantage for one EGFR TKI over another in this setting.
Before prescribing Vizimpro, your doctor will order a molecular test to check for EGFR mutations in your lung cancer. This test can be performed on a tissue biopsy sample or through a blood test (liquid biopsy). Only patients whose tumors have specific EGFR mutations (exon 19 deletion or exon 21 L858R) are candidates for Vizimpro treatment. If your mutation status is unknown, ask your oncologist about getting tested.
What Should You Know Before Taking Vizimpro?
Contraindications
Vizimpro must not be used if you have a known hypersensitivity (allergy) to dacomitinib or to any of the other ingredients in the tablet formulation (listed in the composition section below). Allergic reactions to the medication may present as skin rash, itching, swelling, or difficulty breathing. If you have previously experienced an allergic reaction to any EGFR tyrosine kinase inhibitor, discuss this with your oncologist before starting Vizimpro, as cross-sensitivity may occur.
Warnings and Precautions
Vizimpro can cause inflammation of the lungs (interstitial lung disease or pneumonitis), which can be fatal. Symptoms include new or worsening difficulty breathing, shortness of breath, cough with or without mucus, or fever. If you develop any of these symptoms, stop taking Vizimpro and contact your doctor immediately. Your doctor may need to permanently discontinue treatment.
Before and during treatment with Vizimpro, inform your healthcare provider about any of the following conditions, as they require special monitoring or may affect treatment decisions:
- Lung problems: If you have ever had other lung conditions, these may worsen during treatment with Vizimpro. Certain lung complications can be similar to the symptoms of your lung cancer. Report any new or worsening breathing difficulties, breathlessness, cough (with or without mucus), or fever to your doctor immediately. Interstitial lung disease (ILD) occurred in approximately 3% of patients in clinical trials and can be life-threatening.
- Diarrhea: Diarrhea is very common with Vizimpro and can lead to dehydration, electrolyte imbalances (particularly low potassium levels), and deterioration of kidney function if not managed promptly. It is important to have anti-diarrheal medication (such as loperamide) available at home before starting treatment. At the first sign of increased bowel frequency, begin anti-diarrheal treatment and drink plenty of fluids. Contact your doctor if diarrhea becomes severe or persistent despite treatment.
- Skin reactions: Skin rash (including acneiform dermatitis, eczema, and erythema) is very common with Vizimpro. Early treatment of skin reactions is crucial. Tell your doctor promptly if you develop a skin rash. If the rash worsens or if your skin starts to peel or crack, inform your doctor immediately, as dose modification or treatment interruption may be necessary. Skin reactions may worsen with sun exposure; use protective clothing and sunscreen during treatment.
- Liver problems: Abnormal liver enzyme levels have been reported in patients taking Vizimpro. Symptoms of liver problems include yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-colored) urine, and pale-colored stools. Inform your doctor immediately if you notice any of these symptoms. Your liver function will be monitored through regular blood tests during treatment.
Pregnancy and Breastfeeding
Vizimpro may cause harm to an unborn baby. Women of childbearing potential must use effective contraception during treatment and for at least 17 days after the last dose. If you become pregnant while taking Vizimpro, contact your doctor immediately.
Vizimpro must not be used during pregnancy. Based on its mechanism of action and findings from animal studies, dacomitinib is expected to cause fetal harm when administered to a pregnant woman. The drug’s potent inhibition of EGFR signaling, which is essential for normal embryonic development, poses a significant risk of birth defects or pregnancy loss. If there is any possibility that you could become pregnant, you must use highly effective contraception throughout the duration of treatment and for at least 17 days following the last dose. If you discover that you are pregnant during treatment, contact your oncologist immediately to discuss the implications and next steps.
It is not known whether dacomitinib or its metabolites are excreted in human breast milk. Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with Vizimpro and for at least 17 days after the last dose. Discuss alternative feeding options with your healthcare provider if you are breastfeeding or planning to breastfeed.
Children and Adolescents
The safety and efficacy of Vizimpro have not been established in children and adolescents under 18 years of age. EGFR-mutated NSCLC is extremely rare in pediatric populations. Vizimpro should not be given to patients under 18 years old.
Driving and Operating Machinery
Fatigue and eye irritation may occur in patients taking Vizimpro. If you experience tiredness or if your eyes are irritated, you should exercise caution when driving a vehicle or operating machinery. These symptoms are common during treatment and typically relate to the drug’s effects on rapidly dividing cells in the body, including those on the surface of the eye.
Important Information About Ingredients
Vizimpro film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your physician before taking this medicine. The tablets also contain less than 1 mmol (23 mg) sodium per tablet, meaning they are essentially sodium-free.
How Does Vizimpro Interact with Other Drugs?
Understanding drug interactions with Vizimpro is essential for ensuring both the effectiveness and safety of your treatment. Dacomitinib is metabolized primarily by the enzyme CYP2D6, with a minor contribution from CYP3A4. Additionally, dacomitinib itself acts as a moderate inhibitor of CYP2D6, meaning it can increase the blood levels of other drugs that depend on this enzyme for their breakdown. This bidirectional interaction potential makes it important to inform your doctor about all medications you are taking, including prescription drugs, over-the-counter products, and herbal supplements.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Proton pump inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole) | Significantly reduces dacomitinib absorption due to increased gastric pH | Contraindicated – do not use together; effectiveness of Vizimpro may be severely compromised |
| Procainamide | Dacomitinib inhibits CYP2D6, increasing procainamide blood levels and risk of cardiac arrhythmias | Contraindicated – do not use together due to potential for life-threatening cardiac effects |
| Pimozide | CYP2D6 inhibition by dacomitinib increases pimozide levels, risk of QT prolongation and cardiac arrhythmias | Contraindicated – do not use together |
| Thioridazine | CYP2D6 inhibition by dacomitinib increases thioridazine levels, risk of QT prolongation and cardiac arrhythmias | Contraindicated – do not use together |
Interactions Requiring Dosing Adjustments
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| H2-receptor antagonists (e.g., ranitidine, famotidine) | May reduce dacomitinib absorption by raising gastric pH | Take Vizimpro at least 2 hours before or 10 hours after the H2 blocker |
| Antacids (e.g., calcium carbonate, magnesium hydroxide) | Short-term pH elevation may slightly reduce absorption | May be used; considered a safer alternative to PPIs or H2 blockers |
| Other CYP2D6 substrates (e.g., dextromethorphan, metoprolol, certain SSRIs) | Dacomitinib may increase blood levels of these drugs | Use with caution; dose adjustments of the co-administered drug may be needed |
The interaction between Vizimpro and acid-reducing agents is particularly important to understand. Dacomitinib is a weakly basic compound whose solubility is pH-dependent—it dissolves more readily in acidic conditions. Proton pump inhibitors raise the gastric pH substantially and for a prolonged period, which can dramatically reduce the absorption of dacomitinib from the gastrointestinal tract. For this reason, PPIs are strictly prohibited during treatment. Short-acting antacids represent the safest alternative, as their effect on gastric pH is brief and localized. If an H2-receptor antagonist is necessary, the timing separation (Vizimpro at least 2 hours before or 10 hours after the H2 blocker) allows adequate time for dacomitinib to be absorbed before the gastric pH is significantly altered.
The CYP2D6 inhibitory effect of dacomitinib is clinically significant. Procainamide (used for irregular heart rhythms), pimozide (used in schizophrenia and psychosis), and thioridazine (an antipsychotic) are all CYP2D6 substrates with narrow therapeutic indices. Elevated levels of these drugs can lead to serious cardiac arrhythmias, including potentially fatal QT prolongation and torsades de pointes. Therefore, these combinations are absolutely contraindicated during Vizimpro treatment.
What Is the Correct Dosage of Vizimpro?
Vizimpro should always be taken exactly as prescribed by your doctor or pharmacist. The medication is designed for oral administration, taken once daily at approximately the same time each day. Swallow the tablet whole with a glass of water. You can take it with or without food, as food does not significantly affect the absorption of dacomitinib. Consistency in timing helps maintain stable drug levels in your blood, optimizing the therapeutic effect.
Adults
Standard Adult Dosage
Starting dose: 45 mg orally once daily
Administration: Swallow tablet whole with water; may be taken with or without food
Duration: Continue treatment until disease progression or unacceptable toxicity
Dose modifications: If side effects are not adequately managed, the dose may be reduced in steps: 45 mg → 30 mg → 15 mg. If 15 mg daily is still not tolerated, Vizimpro should be permanently discontinued.
Dose Reduction Schedule
First reduction: 30 mg once daily (one 30 mg tablet)
Second reduction: 15 mg once daily (one 15 mg tablet)
If 15 mg not tolerated: Permanent discontinuation of Vizimpro
Your doctor will decide whether to reduce your dose based on the type and severity of side effects you experience. The most common reasons for dose reduction include severe diarrhea, skin rash, or stomatitis (mouth inflammation). In the ARCHER 1050 trial, approximately 66% of patients required at least one dose reduction, highlighting the importance of proactive side effect management.
Children and Adolescents
Vizimpro is not approved for use in patients under 18 years of age. There are no clinical data supporting the safety or efficacy of dacomitinib in pediatric populations. EGFR-mutated non-small cell lung cancer occurs almost exclusively in adults.
Elderly Patients
No dose adjustment is required for elderly patients based on age alone. In the ARCHER 1050 trial, patients aged 65 years and older showed similar efficacy outcomes to younger patients. However, elderly patients may be more susceptible to certain side effects, particularly diarrhea-related dehydration and skin toxicity. Close monitoring and proactive supportive care are recommended for older adults taking Vizimpro.
Missed Dose
If you miss a dose of Vizimpro or vomit after taking it, do not take a replacement dose. Simply take your next scheduled dose at the usual time. Never take a double dose to make up for a missed one. Missing an occasional dose is unlikely to significantly affect the overall efficacy of your treatment, but try to maintain a consistent daily schedule. If you frequently forget to take your medication, consider setting a daily alarm or using a pill organizer to help establish a routine.
Overdose
If you take more Vizimpro than prescribed, seek medical attention or go to a hospital emergency department immediately. There is no specific antidote for dacomitinib overdose. Treatment is supportive and symptomatic, focusing on managing any adverse effects that may develop. Bring the medication packaging with you so healthcare providers know exactly what you have taken and in what quantity.
Do not stop taking Vizimpro unless your doctor tells you to. Even if you experience side effects, your doctor can often manage these with dose reductions, treatment interruptions, or supportive medications rather than stopping treatment altogether. Discontinuing cancer therapy without medical guidance may allow the disease to progress.
What Are the Side Effects of Vizimpro?
Like all medicines, Vizimpro can cause side effects, although not everyone gets them. Many of the common side effects are related to Vizimpro’s mechanism of action: EGFR is expressed not only in cancer cells but also in normal rapidly dividing tissues such as the skin, gastrointestinal lining, and hair follicles. This explains why skin reactions, diarrhea, and mouth inflammation are so frequently observed. Understanding and managing these side effects proactively is crucial for maintaining treatment quality and ensuring you can continue receiving the therapeutic benefits of Vizimpro.
Contact your doctor immediately if you experience any of the following serious side effects, as you may need urgent medical attention:
Lung inflammation (interstitial lung disease): Common (may affect up to 1 in 10 people). Breathing difficulties, shortness of breath, possibly with cough or fever. This may indicate a serious inflammation of the lungs called interstitial lung disease, which can be fatal. Stop taking Vizimpro and contact your doctor immediately.
Very Common Side Effects
May affect more than 1 in 10 people
- Diarrhea (can lead to dehydration and low potassium levels)
- Skin rash and acneiform dermatitis
- Inflammation of the mouth and lips (stomatitis)
- Nail problems (paronychia, onychoclasis)
- Dry skin
- Decreased appetite
- Dry, red, or itchy eyes
- Weight loss
- Hair loss (alopecia)
- Itching (pruritus)
- Abnormal liver enzymes in blood tests
- Nausea or vomiting
- Redness or pain in the palms of hands or soles of feet (palmar-plantar erythrodysesthesia)
- Fatigue
- Weakness (asthenia)
- Skin cracks (fissures)
- Low potassium levels in the blood (hypokalemia)
Common Side Effects
May affect up to 1 in 10 people
- Interstitial lung disease (ILD) / pneumonitis
- Taste changes (dysgeusia)
- Peeling skin (exfoliation)
- Eye inflammation (conjunctivitis, blepharitis)
- Abnormal body hair growth (hypertrichosis)
- Dehydration
The frequency and severity of side effects often correlate with the dose of Vizimpro. In the ARCHER 1050 clinical trial, approximately 66% of patients required at least one dose reduction, and 10% permanently discontinued treatment due to adverse events. The most common side effects leading to dose reduction were dermatitis acneiform (21%), diarrhea (10%), and stomatitis (4%). With proactive management including early intervention for diarrhea, prophylactic skin care, and timely dose modifications, most patients can continue treatment with an acceptable quality of life.
Managing Common Side Effects
Diarrhea management: Begin anti-diarrheal medication (loperamide) at the first sign of loose or frequent stools. Drink plenty of clear fluids to prevent dehydration. If diarrhea persists for more than 24 hours despite anti-diarrheal medication, or if you experience signs of dehydration (dizziness, dry mouth, reduced urination, dark urine), contact your doctor. Grade 3 or higher diarrhea may require treatment interruption and dose reduction.
Skin care: Start a gentle skin care regimen before beginning Vizimpro treatment. Use fragrance-free moisturizers at least twice daily. Apply broad-spectrum sunscreen (SPF 30 or higher) and wear protective clothing when outdoors, as skin reactions may worsen with sun exposure. Your doctor may prescribe topical treatments (such as topical corticosteroids or antibiotics) or oral antibiotics (such as doxycycline) for management of skin reactions. Report any rash to your doctor early, as timely intervention can prevent progression to more severe skin toxicity.
Stomatitis (mouth sores): Maintain good oral hygiene with gentle, alcohol-free mouthwash. Avoid spicy, acidic, or rough-textured foods. Your doctor may recommend prescription mouthwashes or topical pain relief. Adequate hydration and soft foods can help minimize discomfort.
It is important to report suspected side effects after a medicine has been authorized. This allows continuous monitoring of the medicine’s benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority (e.g., MHRA Yellow Card Scheme in the UK, FDA MedWatch in the US, or EudraVigilance in the EU).
How Should You Store Vizimpro?
Keep Vizimpro out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) stated on the carton and blister packaging. The expiry date refers to the last day of that month. No special storage conditions are required for Vizimpro tablets—they can be stored at standard room temperature.
Vizimpro tablets are supplied in blister packs containing 30 film-coated tablets. Keep the tablets in their original blister packaging until you are ready to take a dose. This protects them from moisture and light, which can degrade the active ingredient over time.
This medicine may pose a risk to the environment. Do not dispose of Vizimpro tablets by flushing them down the toilet or throwing them into household waste. Return any unused or expired medication to your pharmacist for proper disposal. These measures help to protect the environment from pharmaceutical contamination, which is particularly important for anticancer agents.
What Does Vizimpro Contain?
The active substance in Vizimpro is dacomitinib, present as dacomitinib monohydrate. Three tablet strengths are available to allow flexible dosing and dose modifications:
- Vizimpro 15 mg tablets: Each film-coated tablet contains 15 mg dacomitinib. Blue, round, biconvex tablets engraved with “Pfizer” on one side and “DCB15” on the other.
- Vizimpro 30 mg tablets: Each film-coated tablet contains 30 mg dacomitinib. Blue, round, biconvex tablets engraved with “Pfizer” on one side and “DCB30” on the other.
- Vizimpro 45 mg tablets: Each film-coated tablet contains 45 mg dacomitinib. Blue, round, biconvex tablets engraved with “Pfizer” on one side and “DCB45” on the other.
The inactive ingredients (excipients) in the tablet core are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating (Opadry II Blue 85F30716) contains polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide (E171), macrogol (polyethylene glycol), and indigo carmine aluminum lake (E132).
All three strengths are supplied in blister packs containing 30 film-coated tablets, representing a one-month supply at the standard once-daily dosing regimen. The blue color of the tablets and the strength-specific engravings allow for easy identification of the correct dose.
The marketing authorization holder is Pfizer Europe MA EEIG, Brussels, Belgium. The manufacturer is Pfizer Manufacturing Deutschland GmbH, Freiburg im Breisgau, Germany.
Frequently Asked Questions About Vizimpro
Vizimpro (dacomitinib) is used as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific activating EGFR mutations—specifically exon 19 deletion or exon 21 L858R substitution. Before starting treatment, a molecular diagnostic test must confirm the presence of one of these qualifying mutations. Vizimpro is not effective against NSCLC without these specific EGFR mutations.
Vizimpro is a second-generation, irreversible pan-HER inhibitor, distinguishing it from first-generation reversible EGFR inhibitors such as erlotinib (Tarceva) and gefitinib (Iressa). In the ARCHER 1050 trial, Vizimpro demonstrated superior progression-free survival (14.7 months vs 9.2 months) and overall survival (34.1 months vs 26.8 months) compared to gefitinib. However, third-generation EGFR inhibitors like osimertinib (Tagrisso) are now also widely used in the first-line setting, offering additional activity against the T790M resistance mutation. Your oncologist will discuss which EGFR inhibitor is most appropriate for your specific situation.
Proton pump inhibitors (PPIs like omeprazole, esomeprazole, and lansoprazole) must not be used with Vizimpro, as they significantly reduce its absorption and effectiveness. Short-acting antacids are a safer alternative and may be used. If you need an H2-receptor antagonist (such as famotidine), you must take Vizimpro at least 2 hours before or 10 hours after the H2 blocker dose to minimize the interaction.
Diarrhea is one of the most common side effects of Vizimpro and should be treated promptly. Have anti-diarrheal medication (such as loperamide) at home before starting treatment. At the first sign of increased bowel frequency, begin taking loperamide and drink plenty of clear fluids to prevent dehydration. If diarrhea persists beyond 24 hours despite medication, becomes severe (more than 6 stools per day above normal), or if you develop signs of dehydration (dizziness, dry mouth, dark urine), contact your doctor immediately. Your doctor may recommend a treatment break or dose reduction.
No, Vizimpro must not be used during pregnancy. Based on its mechanism of action and animal data, dacomitinib is expected to cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 17 days after the last dose. If you become pregnant while taking Vizimpro, contact your doctor immediately. Breastfeeding is also not recommended during treatment and for at least 17 days after the last dose.
Vizimpro is taken continuously until the cancer progresses (grows or spreads further) or until side effects become too severe to continue treatment, even after dose reductions. In the ARCHER 1050 clinical trial, the median duration of treatment was approximately 14.7 months. Some patients may remain on treatment for significantly longer. Your oncologist will monitor your response through regular imaging scans (typically every 6–12 weeks) and will discuss whether to continue treatment at each assessment.
References
- European Medicines Agency (EMA). Vizimpro (dacomitinib) – Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/vizimpro
- U.S. Food and Drug Administration (FDA). Vizimpro (dacomitinib) – Prescribing Information. Pfizer Inc. Revised 2024. Available at: accessdata.fda.gov
- Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454–1466. doi:10.1016/S1470-2045(17)30608-3
- Mok TS, Cheng Y, Zhou X, et al. Updated overall survival in a randomized study comparing dacomitinib with gefitinib as first-line treatment in patients with advanced non-small-cell lung cancer and EGFR-activating mutations. Drugs. 2021;81(2):257–266. doi:10.1007/s40265-020-01441-6
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 3.2025.
- Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2024;35(1):1–25.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: WHO.
- Ramalingam SS, Janne PA, Mok T, et al. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014;15(12):1369–1378. doi:10.1016/S1470-2045(14)70452-8
Editorial Team
Medical Content
iMedic Medical Editorial Team – Specialists in Thoracic Oncology and Clinical Pharmacology
Medical Review
iMedic Medical Review Board – Independent panel of board-certified physicians
Evidence Standard
Level 1A – Based on systematic reviews and randomized controlled trials (ARCHER 1050)
Guidelines Followed
WHO, EMA SmPC, FDA Label, NCCN Guidelines, ESMO Clinical Practice Guidelines
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