Vizimpro vs Tagrisso: How These EGFR Drugs Differ

Written by Dr. Zack Ferris in TheSkyMeds Editorial Standards

Medically reviewed by Jonathan Reed, Medical Content Reviewer Sept 21 2026

Vizimpro and Tagrisso are targeted cancer medicines used in certain forms of EGFR-mutated non-small cell lung cancer (NSCLC), but they are not interchangeable drugs. Vizimpro contains dacomitinib, a second-generation EGFR tyrosine kinase inhibitor (TKI), while Tagrisso contains osimertinib, a third-generation EGFR TKI. Both have roles in tumors with common EGFR exon 19 deletion or exon 21 L858R mutations, yet their U.S. indications, clinical evidence, side-effect profiles, and treatment settings differ substantially. Tagrisso has U.S. indications spanning resected, unresectable stage III, and locally advanced or metastatic disease, whereas Vizimpro's U.S. indication is narrower. Comparing Vizimpro vs Tagrisso therefore involves much more than comparing two tablets that block EGFR. This guide explains where each medicine is used, how they work, their major safety differences, and why EGFR testing and the stage of lung cancer matter when treatment is selected.

• •What Are Vizimpro and Tagrisso?
• •Vizimpro vs Tagrisso: What Are the Main Differences?
• •How Do Dacomitinib and Osimertinib Work?
• •What Does the Clinical Evidence Show?
• •How Do Vizimpro and Tagrisso Side Effects Differ?
• •Why Does EGFR Testing Matter Before Treatment?
• •When Should Patients Contact Their Cancer Care Team?
• •Conclusion
• •Frequently Asked Questions

What Are Vizimpro and Tagrisso?

Vizimpro and Tagrisso are oral targeted therapies known as EGFR tyrosine kinase inhibitors. They block signaling through epidermal growth factor receptor (EGFR), a protein that can drive cancer-cell growth when certain mutations are present.

Vizimpro is the brand name for dacomitinib. It is a second-generation, irreversible EGFR TKI. Its U.S. indication is first-line treatment of metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation detected by an FDA-approved test.

Tagrisso is the brand name for osimertinib. It is a third-generation EGFR TKI and has several U.S. indications involving EGFR exon 19 deletion or exon 21 L858R-mutated NSCLC. These extend across different stages and treatment settings.

The National Cancer Institute overview of NSCLC treatment describes both dacomitinib and osimertinib among EGFR-directed treatments and summarizes the major clinical trials supporting these therapies.

The biggest difference between Vizimpro and Tagrisso is not simply that one is a second-generation TKI and the other is third-generation. Their approved treatment settings, supporting evidence, activity characteristics, and safety considerations also differ.

Vizimpro vs Tagrisso: What Are the Main Differences?

Both medicines target EGFR-driven lung cancer, but Tagrisso currently has a broader range of FDA-approved NSCLC treatment settings than Vizimpro. Vizimpro's U.S. indication is specifically first-line treatment of metastatic disease with the two common EGFR mutations.

Vizimpro vs Tagrisso at a glance

Feature	Vizimpro	Tagrisso
Generic name	Dacomitinib	Osimertinib
EGFR TKI generation	Second generation	Third generation
Form	Oral tablet	Oral tablet
Common EGFR mutations relevant to current U.S. indications	Exon 19 deletion or exon 21 L858R	Exon 19 deletion or exon 21 L858R
First-line metastatic NSCLC	FDA-approved	FDA-approved
After complete tumor resection	Not a U.S. indication	FDA-approved in eligible EGFR-mutated NSCLC
Unresectable stage III after chemoradiation without progression	Not a U.S. indication	FDA-approved in eligible patients
First-line with platinum-based chemotherapy	Not a U.S. indication	FDA-approved in locally advanced or metastatic disease
Important safety concerns	ILD, diarrhea, skin reactions, fetal harm	Includes ILD/pneumonitis, QTc prolongation, cardiomyopathy, eye toxicity and fetal harm

The table summarizes U.S. regulatory information and should not be used to choose treatment without an oncology team.

How do their FDA-approved uses differ?

Vizimpro has a relatively focused U.S. indication. It is FDA-approved as first-line therapy for metastatic NSCLC when an FDA-approved test detects an EGFR exon 19 deletion or exon 21 L858R mutation.

Tagrisso has accumulated several indications. In addition to first-line treatment of metastatic EGFR-mutated NSCLC, FDA records show approval as adjuvant treatment after tumor resection in eligible adults.

In February 2024, the FDA also approved osimertinib with pemetrexed and platinum-based chemotherapy as first-line treatment for eligible locally advanced or metastatic EGFR-mutated NSCLC. In September 2024, another indication was added for eligible patients with unresectable stage III disease that had not progressed during or after platinum-based chemoradiation.

These are distinct clinical situations. An indication in early-stage disease after surgery, for example, should not be assumed to apply to metastatic disease or vice versa.

How Do Dacomitinib and Osimertinib Work?

Both drugs interrupt EGFR signaling, but they have different molecular targeting profiles. Dacomitinib irreversibly inhibits members of the ErbB/HER receptor family, whereas osimertinib was developed as a mutant-selective EGFR inhibitor with activity against sensitizing EGFR mutations and the resistance-associated T790M mutation.

How Vizimpro works

Dacomitinib binds irreversibly to its targets within the ErbB family. Blocking these signaling pathways can reduce signals that EGFR-mutated cancer cells use for growth and survival.

The National Cancer Institute describes dacomitinib as a tyrosine kinase inhibitor used to treat NSCLC with certain EGFR gene mutations.

Dacomitinib's pivotal first-line ARCHER 1050 study compared it with gefitinib rather than directly with osimertinib. The trial demonstrated longer progression-free survival with dacomitinib than gefitinib, but adverse events and dose reductions were common.

How Tagrisso works

Osimertinib irreversibly inhibits mutant forms of EGFR and has activity against the T790M resistance mutation as well as common sensitizing EGFR mutations.

One clinically important characteristic is its activity in the central nervous system (CNS)—the brain and spinal cord. In the FLAURA study summarized by the National Cancer Institute, CNS progression occurred less frequently with osimertinib than with the comparator first-generation EGFR TKIs.

This matters because EGFR-mutated NSCLC can spread to the brain. However, an individual's brain metastases, symptoms, previous treatment, and overall cancer characteristics need to be considered by the oncology team rather than using CNS activity alone to make a treatment decision.

What Does the Clinical Evidence Show?

Both medicines have randomized clinical-trial evidence in EGFR-mutated advanced NSCLC, but their pivotal trials used different comparators. This makes simple numerical comparisons between separate studies potentially misleading.

Evidence supporting Vizimpro

The phase III ARCHER 1050 trial compared first-line dacomitinib with gefitinib in patients with advanced NSCLC carrying EGFR exon 19 deletion or L858R mutations.

According to the National Cancer Institute summary, median progression-free survival—the period patients lived without their cancer progressing—was 14.7 months with dacomitinib and 9.2 months with gefitinib. Median overall survival was reported as 34.1 versus 26.8 months, respectively.

Side effects frequently required treatment adjustment. Dose reductions occurred in 66% of patients receiving dacomitinib versus 8% receiving gefitinib in the trial.

Evidence supporting Tagrisso

The phase III FLAURA trial compared first-line osimertinib with the first-generation EGFR TKIs gefitinib or erlotinib.

The NCI reports median progression-free survival of 18.9 months with osimertinib versus 10.2 months with the comparator EGFR TKIs. Median overall survival was 38.6 versus 31.8 months, respectively.

Tagrisso has subsequently been studied in additional treatment settings. For unresectable stage III EGFR-mutated NSCLC after chemoradiation, the LAURA trial produced a median progression-free survival of 39.1 months with osimertinib versus 5.6 months with placebo, leading to the 2024 FDA approval in this setting.

Can the trial numbers be compared directly?

Not reliably. ARCHER 1050 and FLAURA were separate trials involving different study designs and comparator treatments, so putting their survival numbers side by side does not create a head-to-head Vizimpro-versus-Tagrisso trial.

Clinical decisions should instead consider the full evidence, approved indication, cancer stage, EGFR mutation, CNS disease, previous treatment, toxicity profile, and current oncology guidelines.

How Do Vizimpro and Tagrisso Side Effects Differ?

Both drugs can cause diarrhea, rash, and potentially serious lung toxicity, but their safety profiles are not identical. Dacomitinib is particularly associated with gastrointestinal and dermatologic toxicity, while osimertinib has additional clinically important cardiac and eye-related warnings.

 Important safety considerations with Vizimpro and Tagrisso

Safety issue	Vizimpro	Tagrisso
Diarrhea	Common and can become severe	Can occur
Rash/skin reactions	Common and can require dose adjustment	Common
Nail problems	Can occur	Can occur
Interstitial lung disease/pneumonitis	Serious warning	Serious warning
QTc prolongation	Not a defining labeled warning	Important warning/monitoring consideration
Cardiomyopathy	Not a defining labeled warning	Important warning/monitoring consideration
Eye toxicity	Not a defining major warning	Keratitis and other ocular toxicity require attention
Pregnancy	Can cause fetal harm	Can cause fetal harm

The frequency and severity of an adverse effect cannot be inferred simply from whether it appears in this table. Product labeling and individual patient factors determine monitoring and management.

Vizimpro side effects

In Vizimpro prescribing information, common adverse reactions include diarrhea, rash, inflammation around the nails (paronychia), mouth inflammation, decreased appetite, dry skin, weight loss, hair loss, cough, and itching.

Diarrhea can become severe and may require treatment interruption and subsequent dose reduction. Significant skin reactions can likewise require treatment modification.

The official Vizimpro prescribing information also warns about interstitial lung disease (ILD), a potentially serious inflammatory or scarring condition affecting the lungs. Confirmed ILD requires permanent discontinuation according to the U.S. label.

Tagrisso side effects

Tagrisso also causes gastrointestinal and skin-related adverse effects, but its safety monitoring has some different priorities.

Osimertinib labeling includes important warnings concerning ILD/pneumonitis, QTc interval prolongation, cardiomyopathy, keratitis and other eye toxicity, and fetal harm. These risks do not occur in every patient, but certain conditions or symptoms can require additional monitoring, interruption, dose modification, or discontinuation.

Treatment combinations can also change the side-effect profile. For example, the FDA approval of Tagrisso with chemotherapy reports frequent blood-count abnormalities alongside rash, diarrhea, mouth inflammation, nail toxicity, and dry skin in patients receiving the combination.

Why Does EGFR Testing Matter Before Treatment?

EGFR testing is essential because neither drug is intended simply for any person with lung cancer. Their use depends on identifying relevant molecular changes in the tumor and matching those findings to an approved treatment setting.

EGFR stands for epidermal growth factor receptor. Mutations can alter the receptor and cause persistent growth signals that help cancer cells multiply.

Two particularly important mutations are:

• EGFR exon 19 deletions

• EGFR exon 21 L858R substitution

Both appear in the U.S. indications relevant to first-line metastatic treatment with Vizimpro and Tagrisso.

Testing can sometimes use tumor tissue or circulating tumor DNA obtained through a blood sample, depending on the test and clinical circumstances. However, the FDA information on EGFR companion diagnostic testing cautions that a negative plasma result does not necessarily mean the tumor is negative for the relevant genomic finding; tissue testing may therefore be appropriate when feasible.

The exact mutation matters because “EGFR-positive” is not sufficiently precise for every treatment decision. Other EGFR alterations, including exon 20 insertions and less common mutations, can have different treatment approaches.

When Should Patients Contact Their Cancer Care Team?

Patients taking Vizimpro or Tagrisso should promptly report new or worsening symptoms because some treatment complications need early evaluation. Cancer treatment should not be stopped, restarted, or dose-adjusted without instructions from the oncology team unless emergency medical care is required.

Contact the cancer care team promptly for new or worsening shortness of breath, cough, or fever, because these symptoms can indicate interstitial lung disease or pneumonitis. Severe or persistent diarrhea also deserves attention, particularly with Vizimpro, because dehydration and other complications can develop.

Patients taking Tagrisso should also report symptoms that could suggest heart problems, such as unusual shortness of breath, swelling, fainting, marked dizziness, or a noticeably abnormal heartbeat. New eye pain, redness, light sensitivity, or vision changes also warrant assessment.

Severe blistering or peeling skin, facial or throat swelling, difficulty breathing, fainting, or other symptoms suggesting a medical emergency require urgent medical attention.

Pregnancy prevention is another important consideration because EGFR TKIs can cause fetal harm. Patients who are pregnant, may become pregnant, or are planning pregnancy should discuss treatment-specific precautions with their oncology team.

Conclusion

The Vizimpro vs Tagrisso comparison involves two oral EGFR-targeted therapies with meaningful differences. Vizimpro (dacomitinib) is a second-generation TKI with a U.S. indication for first-line treatment of certain EGFR-mutated metastatic NSCLC. Tagrisso (osimertinib), a third-generation TKI, has broader U.S. indications covering several stages and treatment settings and has distinct CNS and safety considerations.

Neither medicine should be selected from a simple drug comparison alone. EGFR mutation results, cancer stage, brain involvement, previous treatment, other medical conditions, and expected toxicities all influence treatment planning. Patients should discuss these factors and current treatment options with their oncology team rather than changing EGFR therapy independently.

Frequently Asked Questions

1. Is Vizimpro the same as Tagrisso?

No. Vizimpro contains dacomitinib, a second-generation EGFR tyrosine kinase inhibitor, while Tagrisso contains osimertinib, a third-generation EGFR inhibitor. Both target certain EGFR-mutated lung cancers, but their approved uses and safety profiles differ.

2. Do Vizimpro and Tagrisso treat the same EGFR mutations?

They overlap for two important mutations: EGFR exon 19 deletion and exon 21 L858R. However, having one of these mutations does not by itself determine treatment. Cancer stage, previous therapy, CNS disease, regulatory indication, and other clinical factors also matter.

3. Which drug is newer, Vizimpro or Tagrisso?

Tagrisso is classified as a third-generation EGFR TKI, while Vizimpro is a second-generation EGFR TKI. In the United States, osimertinib was initially approved in 2015 and dacomitinib in 2018, so TKI “generation” does not simply describe the date a medicine reached the market.

4. Can Vizimpro or Tagrisso be used when lung cancer has spread to the brain?

Brain involvement requires individualized oncology assessment. Osimertinib has documented CNS activity, and the FLAURA trial reported less CNS progression with osimertinib than comparator first-generation EGFR TKIs. Treatment still depends on symptoms, mutation status, previous therapy, and other clinical factors.

5. Do Vizimpro and Tagrisso have the same side effects?

No. Both can cause diarrhea, skin problems, and serious lung toxicity, but their overall safety profiles differ. Vizimpro commonly produces gastrointestinal and dermatologic toxicity, while Tagrisso has additional important warnings involving heart rhythm, heart muscle function, and eye toxicity.

6. Can someone switch from Vizimpro to Tagrisso?

A treatment change may be considered in some clinical circumstances, but it is not an automatic substitution. The reason for stopping treatment, evidence of cancer progression, molecular findings, previous therapies, side effects, and available treatment options need evaluation by the oncology team before changing EGFR therapy.