TAGRISSO: Uses, Dosage & Side Effects
A third-generation EGFR tyrosine kinase inhibitor for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC), including adjuvant, consolidation, and metastatic settings
TAGRISSO (osimertinib) is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor used to treat non-small cell lung cancer (NSCLC) with specific EGFR mutations. Taken as an oral tablet once daily, TAGRISSO selectively targets cancer cells harboring EGFR exon 19 deletions, exon 21 L858R substitution mutations, and the T790M resistance mutation. It is approved for use as adjuvant therapy after surgery, as consolidation following chemoradiotherapy, and as first-line or subsequent treatment for metastatic disease. TAGRISSO has demonstrated significant improvements in progression-free survival and overall survival across multiple landmark clinical trials, making it a cornerstone of EGFR-mutated NSCLC treatment worldwide.
Quick Facts: TAGRISSO
Key Takeaways
- TAGRISSO (osimertinib) is a third-generation EGFR tyrosine kinase inhibitor that specifically targets EGFR exon 19 deletions, exon 21 L858R mutations, and the T790M resistance mutation in non-small cell lung cancer.
- It is approved as adjuvant therapy after complete tumor resection, as consolidation after chemoradiotherapy for unresectable stage III NSCLC, and as first-line treatment for metastatic EGFR-mutated NSCLC (alone or combined with pemetrexed and platinum chemotherapy).
- The standard dose is 80 mg taken orally once daily with or without food; the tablet can be dispersed in water for patients with swallowing difficulties.
- Serious potential side effects include interstitial lung disease, QTc prolongation, Stevens-Johnson syndrome, aplastic anemia, and heart failure – patients should report breathing difficulties, heart palpitations, or severe skin reactions immediately.
- St. John’s wort is strictly contraindicated, and strong CYP3A4 inducers (phenytoin, carbamazepine, rifampicin) can significantly reduce TAGRISSO effectiveness; effective contraception is required for both women (2 months post-treatment) and men (4 months post-treatment).
What Is TAGRISSO and What Is It Used For?
TAGRISSO contains the active substance osimertinib, which belongs to a class of medications known as protein kinase inhibitors. More specifically, osimertinib is a third-generation, irreversible EGFR (epidermal growth factor receptor) tyrosine kinase inhibitor (TKI). The EGFR protein sits on the surface of cells and, when activated, sends signals that promote cell growth and division. In certain lung cancers, mutations in the gene encoding EGFR cause the receptor to be permanently switched on, driving uncontrolled cell proliferation. TAGRISSO works by covalently binding to a specific site (cysteine-797) on the mutated EGFR protein, permanently blocking its signaling activity and thereby slowing or stopping the growth of cancer cells.
What makes TAGRISSO unique among EGFR inhibitors is its selectivity for mutant forms of EGFR over the normal (wild-type) form. This selectivity translates into greater anticancer activity against EGFR-mutated tumors while producing fewer side effects related to inhibition of normal EGFR function in healthy tissues, such as the skin and gastrointestinal tract. Osimertinib was specifically designed to target not only the common EGFR-sensitizing mutations – exon 19 deletions and the exon 21 L858R point mutation – but also the T790M resistance mutation that frequently develops in patients treated with earlier-generation EGFR TKIs such as erlotinib or gefitinib.
TAGRISSO is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 80–85% of all lung cancer cases worldwide. Among patients with NSCLC, roughly 10–15% of patients in Western populations and 30–50% in East Asian populations have tumors harboring EGFR mutations. Identifying these mutations through molecular testing is essential, as it determines whether a patient is likely to respond to TAGRISSO.
Approved Indications
TAGRISSO is approved by regulatory authorities worldwide, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), for several distinct clinical situations:
- Adjuvant therapy after complete surgical resection: TAGRISSO may be prescribed as a solo treatment after surgery that has completely removed the cancer, to reduce the risk of the cancer returning. This use is for patients whose tumors carry EGFR exon 19 deletions or exon 21 L858R mutations. The landmark ADAURA trial demonstrated a dramatic improvement in disease-free survival, establishing TAGRISSO as the standard of care in this setting.
- Consolidation after chemoradiotherapy: For patients with locally advanced (stage III) NSCLC that cannot be removed surgically and that has responded to or stabilized after concurrent platinum-based chemoradiotherapy, TAGRISSO can be used as consolidation therapy. The LAURA trial showed significant progression-free survival benefit for patients with EGFR exon 19 deletion or exon 21 L858R mutation.
- First-line treatment for metastatic NSCLC (monotherapy): TAGRISSO is used as the first cancer medicine for patients whose NSCLC has spread to other parts of the body (metastatic disease) and whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations. The pivotal FLAURA trial demonstrated superior overall survival compared with earlier-generation EGFR TKIs, and TAGRISSO also showed significant activity against brain metastases.
- First-line treatment combined with chemotherapy: TAGRISSO can be prescribed in combination with pemetrexed and a platinum-containing chemotherapy agent as the first treatment for metastatic EGFR-mutated NSCLC. The FLAURA2 trial showed improved progression-free survival with this combination compared with TAGRISSO alone.
- Treatment after prior EGFR TKI therapy (T790M-positive): If a patient’s cancer has worsened during treatment with earlier EGFR inhibitors and testing reveals the T790M resistance mutation, TAGRISSO may be prescribed as a subsequent treatment. The AURA3 trial demonstrated significantly superior progression-free survival over platinum-based doublet chemotherapy in this setting.
Before starting TAGRISSO, your oncologist will order molecular testing (also called biomarker testing or genomic profiling) on a sample of your tumor tissue or through a liquid biopsy (blood test). This testing identifies whether your cancer carries specific EGFR mutations. The results are essential for determining whether TAGRISSO is the right treatment for you. Testing typically takes 1–2 weeks, and results guide the entire treatment strategy.
What Should You Know Before Taking TAGRISSO?
Contraindications
There are specific situations in which TAGRISSO must not be used. Understanding these absolute contraindications is critical before treatment begins, as failure to observe them can lead to serious or life-threatening consequences.
- Hypersensitivity: Do not take TAGRISSO if you are allergic to osimertinib or any of the other ingredients in the tablets (mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, and black iron oxide).
- St. John’s wort (Hypericum perforatum): This herbal supplement is an absolute contraindication. St. John’s wort is a potent inducer of CYP3A4, the enzyme primarily responsible for metabolizing osimertinib. Concurrent use can dramatically reduce osimertinib blood levels, potentially rendering the treatment ineffective against the cancer.
Warnings and Precautions
Before starting TAGRISSO and throughout your treatment, it is important to discuss the following with your healthcare provider:
TAGRISSO can cause inflammation of the lungs that may be life-threatening. If you experience sudden difficulty breathing accompanied by cough or fever, contact your doctor immediately. Treatment may need to be permanently discontinued. This occurs in up to 1 in 10 patients and some cases have been fatal.
- Lung inflammation (interstitial lung disease): Tell your doctor if you have ever had lung inflammation or any chronic respiratory condition. Symptoms of ILD include sudden shortness of breath, cough, and fever. Your doctor may need to discontinue TAGRISSO permanently if ILD develops.
- Heart problems: TAGRISSO can cause QTc prolongation (changes in the electrical activity of the heart) and reduced heart function (decreased left ventricular ejection fraction). Tell your doctor about any history of heart disease, irregular heartbeat, or if you are taking any medications that affect heart rhythm. You may need regular heart monitoring including ECGs and echocardiograms.
- Eye problems: Keratitis (inflammation of the cornea) has been reported with TAGRISSO. Report any new eye symptoms such as excessive tearing, light sensitivity, eye pain, redness, or vision changes to your doctor promptly.
- Hepatitis B: If you have ever had or currently have hepatitis B infection, tell your doctor before starting TAGRISSO. The medication may cause reactivation of the hepatitis B virus. Signs of reactivation include increasing fatigue and yellowing of the skin or whites of the eyes (jaundice).
- Severe skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These are rare but potentially life-threatening conditions characterized by red or purple rash with blistering, skin peeling, and sores in the mouth, throat, nose, and genitals. Seek immediate medical attention if you experience widespread skin peeling.
- Aplastic anemia: A rare blood disorder in which the bone marrow stops producing adequate blood cells has been reported. Signs include persistent fever, unexplained bruising or bleeding, increasing fatigue, pale skin, and frequent infections.
Contact your doctor immediately if you experience: sudden difficulty breathing with cough or fever; rapid or irregular heartbeat with dizziness, chest discomfort, or fainting; widespread skin peeling or blistering; excessive eye tearing with pain, redness, or vision changes; or persistent fever with unexplained bruising or bleeding.
Children and Adolescents
TAGRISSO has not been studied in children or adolescents. It should not be given to patients under 18 years of age. Non-small cell lung cancer with EGFR mutations is predominantly an adult disease, and the safety and efficacy of osimertinib in the pediatric population have not been established.
Pregnancy and Breastfeeding
TAGRISSO should not be used during pregnancy unless clearly necessary and only after careful consideration by your oncologist of the benefits versus the risks. Based on its mechanism of action and animal data, osimertinib may cause harm to a developing fetus. If you are pregnant, think you might be pregnant, or are planning to become pregnant, talk to your doctor before taking this medicine.
If you become pregnant during treatment, notify your doctor immediately. Your doctor will determine whether you should continue taking TAGRISSO based on your individual clinical situation.
Contraception requirements: Both women and men of reproductive potential must use effective contraception during treatment with TAGRISSO. TAGRISSO may interfere with the effectiveness of hormonal contraceptives (such as birth control pills), so alternative or additional methods should be discussed with your doctor.
- Women: Continue using effective contraception for at least 2 months after the last dose of TAGRISSO.
- Men: Continue using effective contraception for at least 4 months after the last dose, as osimertinib may be transferred to semen.
Breastfeeding: Do not breastfeed during treatment with TAGRISSO. It is not known whether osimertinib passes into human breast milk, and a risk to the nursing infant cannot be excluded.
Driving and Operating Machinery
TAGRISSO has no or negligible effect on the ability to drive and operate machinery. However, patients should be aware that side effects such as fatigue or dizziness may occur, and should exercise appropriate caution.
How Does TAGRISSO Interact with Other Drugs?
Drug interactions are an important consideration with TAGRISSO because osimertinib is metabolized primarily by the CYP3A4 and CYP3A5 enzyme systems, and it can also affect certain drug transport proteins (BCRP and P-glycoprotein). These interactions can either reduce the effectiveness of TAGRISSO or alter the effects of other medications you may be taking.
Drugs That Reduce TAGRISSO Effectiveness
The following medications are strong inducers of CYP3A4 and can significantly reduce blood levels of osimertinib, potentially making the treatment less effective or ineffective against your cancer. These should be avoided:
| Medication | Used For | Risk Level | Action |
|---|---|---|---|
| St. John’s wort | Mild depression and anxiety (herbal) | Contraindicated | Must not be used together |
| Phenytoin | Epileptic seizures | Major | Avoid; discuss alternatives |
| Carbamazepine | Epileptic seizures | Major | Avoid; discuss alternatives |
| Phenobarbital | Epileptic seizures | Major | Avoid; discuss alternatives |
| Rifampicin | Tuberculosis (TB) | Major | Avoid; discuss alternatives |
| Rifabutin | Tuberculosis (TB) | Major | Avoid; discuss alternatives |
Drugs Affected by TAGRISSO
TAGRISSO can alter the blood levels and effects of the following medications by inhibiting drug transport proteins (BCRP and P-glycoprotein). Your doctor may need to monitor you more closely or adjust doses of these medications:
| Medication | Used For | Effect | Clinical Advice |
|---|---|---|---|
| Rosuvastatin | Lowering cholesterol | Increased levels (BCRP inhibition) | Monitor for muscle-related side effects |
| Hormonal contraceptives | Birth control | May reduce effectiveness | Use additional non-hormonal methods |
| Bosentan | Pulmonary hypertension | Altered levels | Discuss with your doctor |
| Efavirenz / Etravirine | HIV/AIDS | Altered levels | Discuss with your doctor |
| Modafinil | Sleep disorders | Altered levels | Discuss with your doctor |
| Dabigatran | Blood clot prevention | Increased levels (P-gp inhibition) | Monitor for signs of bleeding |
| Digoxin | Heart rhythm / heart failure | Increased levels (P-gp inhibition) | Monitor digoxin levels closely |
| Aliskiren | High blood pressure | Increased levels (P-gp inhibition) | Monitor blood pressure and side effects |
Always inform your doctor, pharmacist, or nurse about all medications you are currently taking, have recently taken, or plan to take. This includes prescription medications, over-the-counter drugs, herbal remedies, and dietary supplements. Your medical team can then evaluate potential interactions and ensure the safest and most effective treatment plan.
What Is the Correct Dosage of TAGRISSO?
Always take TAGRISSO exactly as your doctor or pharmacist has instructed. Do not change your dose or stop taking TAGRISSO without consulting your doctor first, as consistent treatment is important for the best possible outcome. The dosing is the same regardless of whether TAGRISSO is being used as adjuvant therapy, consolidation, or for metastatic disease.
Adults
Standard Dosing
Monotherapy: One 80 mg tablet taken orally once daily.
Combination with chemotherapy: One 80 mg tablet taken orally once daily, combined with pemetrexed and a platinum-containing chemotherapy agent administered according to their standard dosing schedules.
Your doctor may reduce your dose to one 40 mg tablet daily if you experience significant side effects.
How to Take TAGRISSO
- Swallow the tablet whole with water. Do not crush, break, or chew the tablet.
- Take TAGRISSO at the same time every day for best results.
- You can take it with or without food.
- Difficulty swallowing: Place the tablet in a glass with approximately 50 ml (about two-thirds of a drinking glass) of still, non-carbonated water. Stir until the tablet breaks into very small pieces (it will not dissolve completely). Drink the mixture immediately. Rinse the glass with another 50 ml of water and drink that as well to ensure you receive the full dose.
Children and Adolescents
TAGRISSO is not approved for use in patients under 18 years of age. Safety and efficacy have not been established in this population.
Elderly Patients
No dose adjustment is required based on age. Clinical trials have included patients across a wide age range, and the safety and efficacy profile is generally consistent in elderly patients. However, elderly patients may be more susceptible to certain side effects such as interstitial lung disease and cardiac effects, and closer monitoring may be warranted.
Missed Dose
If you forget to take a dose of TAGRISSO, take it as soon as you remember. However, if it is less than 12 hours until your next scheduled dose, skip the missed dose and take your next dose at the normal planned time. Do not take a double dose to make up for a missed one. Missing an occasional dose is unlikely to significantly affect your treatment, but try to maintain your regular schedule as consistently as possible.
Overdose
If you accidentally take more TAGRISSO than prescribed, contact your doctor or nearest hospital emergency department immediately. There is no specific antidote for osimertinib overdose. Treatment would be supportive, focusing on managing any symptoms that develop. Bring the medicine packaging with you so healthcare providers can identify what you have taken.
It is crucial that you continue taking TAGRISSO every day for the entire duration prescribed by your doctor. Do not stop treatment because you feel better or because of mild side effects. Stopping treatment prematurely could allow the cancer to progress. Always discuss any concerns about continuing treatment with your oncologist.
What Are the Side Effects of TAGRISSO?
Like all medicines, TAGRISSO can cause side effects, although not everyone experiences them. The side effects listed below are based on clinical trial data and post-marketing surveillance. Understanding potential side effects helps you recognize them early and seek appropriate medical care when needed.
TAGRISSO Monotherapy Side Effects
The following side effects have been reported in patients receiving TAGRISSO as a single agent:
Very Common
May affect more than 1 in 10 patients
- Diarrhea – may come and go during treatment; tell your doctor if it becomes persistent or severe
- Skin and nail problems – including rash, dry skin, itching, and redness around fingernails; more common in sun-exposed areas; use moisturizers regularly
- Stomatitis – inflammation of the mouth lining or mouth sores
- Decreased appetite
- Itchy skin (pruritus)
Common
May affect up to 1 in 10 patients
- Interstitial lung disease / pneumonitis – seek immediate medical attention
- Radiation pneumonitis (lung inflammation from radiation therapy to the chest)
- QTc prolongation (changes in heart electrical activity) – may cause palpitations, dizziness, fainting
- Nosebleeds (epistaxis)
- Hair loss (alopecia)
- Hives (urticaria)
- Hand-foot syndrome – redness, swelling, tingling, or cracking skin on palms and soles
- Increased blood creatinine (kidney function marker)
- Increased creatine phosphokinase (muscle enzyme)
- Decreased white blood cell counts (leukocytes, lymphocytes, neutrophils)
- Decreased platelet count
Uncommon
May affect up to 1 in 100 patients
- Keratitis – eye inflammation causing tearing, light sensitivity, pain, redness, or vision changes
- Erythema multiforme – target-like skin rashes resembling rings
- Cutaneous vasculitis – inflammation of blood vessels in the skin (bruise-like or non-blanching red patches)
- Myositis – muscle inflammation causing pain or weakness
- Skin hyperpigmentation – grayish or darker skin areas
Rare
May affect up to 1 in 1,000 patients
- Stevens-Johnson syndrome (SJS) – severe skin reaction with blistering and peeling; seek immediate medical attention
- Aplastic anemia – bone marrow failure causing low blood counts; seek immediate medical attention
Not Known
Frequency cannot be estimated from available data
- Toxic epidermal necrolysis (TEN) – widespread severe skin peeling
- Hepatitis B reactivation
- Heart failure / decreased left ventricular ejection fraction
Additional Side Effects with Combination Chemotherapy
When TAGRISSO is given in combination with pemetrexed and a platinum-containing chemotherapy, additional or more frequent side effects may occur. The chemotherapy components contribute their own side effect profiles. The following additional patterns have been observed in clinical trials of the combination regimen:
Very Common (Combination Therapy)
May affect more than 1 in 10 patients
- Diarrhea
- Skin and nail problems
- Stomatitis (mouth sores)
- Decreased appetite
- Decreased white blood cell counts (leukocytes, lymphocytes, neutrophils)
- Decreased platelet count
- Increased blood creatinine
Common (Combination Therapy)
May affect up to 1 in 10 patients
- Nosebleeds (epistaxis)
- Itchy skin (pruritus)
- Hair loss (alopecia)
- Erythema multiforme (target-like rashes)
- Hives (urticaria)
- Skin hyperpigmentation
- Hand-foot syndrome
- Increased creatine phosphokinase
Diarrhea: Stay well hydrated and eat small, frequent meals. Your doctor may prescribe anti-diarrheal medications such as loperamide. Skin problems: Use fragrance-free moisturizers regularly, protect skin from sun exposure, and use gentle cleansers. Mouth sores: Use a soft toothbrush, rinse with salt water, and avoid spicy or acidic foods. Report any side effects that worsen or do not improve to your healthcare team.
If you experience any side effect not listed here, or if any listed side effect becomes severe, please inform your doctor, pharmacist, or nurse. You can also report suspected side effects to your national medicines regulatory agency, as this helps monitor the overall benefit-risk balance of the medicine.
How Should You Store TAGRISSO?
Proper storage of TAGRISSO ensures the medicine remains effective and safe throughout its shelf life. The following guidelines should be observed:
- Keep out of sight and reach of children. Store the medicine in a safe location that children cannot access.
- Expiry date: Do not use this medicine after the expiry date printed on the blister foil and carton after “EXP.” The expiry date refers to the last day of the stated month.
- Storage conditions: No special storage conditions are required. Store at room temperature.
- Packaging integrity: Do not use the medicine if the packaging appears damaged or shows any signs of tampering.
- Disposal: Do not throw away medicines via household waste or wastewater. Ask your pharmacist how to safely dispose of medicines that are no longer needed. These measures help protect the environment.
What Does TAGRISSO Contain?
Active Ingredient
The active substance is osimertinib (as mesylate salt). Each 40 mg film-coated tablet contains 40 mg of osimertinib, and each 80 mg film-coated tablet contains 80 mg of osimertinib.
Inactive Ingredients (Excipients)
The other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, and black iron oxide.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially sodium-free. This is important for patients on sodium-restricted diets.
Appearance and Pack Sizes
- TAGRISSO 40 mg: Beige, film-coated, round, biconvex tablets marked with “AZ” and “40” on one side and nothing on the other.
- TAGRISSO 80 mg: Beige, film-coated, oval, biconvex tablets marked with “AZ” and “80” on one side and nothing on the other.
TAGRISSO is supplied in blisters containing either 30 × 1 film-coated tablets (3 blisters of 10 tablets each) or 28 × 1 film-coated tablets (4 blisters of 7 tablets each), packaged in cartons.
The marketing authorization holder is AstraZeneca AB, based in Sweden. TAGRISSO is manufactured by AstraZeneca AB at their facility in Södertälje, Sweden, and is distributed worldwide through AstraZeneca’s network of regional affiliates.
Frequently Asked Questions About TAGRISSO
TAGRISSO (osimertinib) is used to treat non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. It is approved as adjuvant therapy after complete surgical resection of the tumor, as consolidation therapy after chemoradiotherapy for unresectable locally advanced disease, as first-line treatment for metastatic EGFR-mutated NSCLC (either alone or in combination with chemotherapy), and as treatment for T790M-positive NSCLC that has progressed on prior EGFR TKI therapy. Your oncologist will determine which setting applies to your situation based on molecular testing of your tumor.
TAGRISSO is a third-generation EGFR tyrosine kinase inhibitor that works by irreversibly binding to the mutated EGFR protein on lung cancer cells. The EGFR protein, when mutated, sends constant signals telling cancer cells to grow and divide uncontrollably. By blocking this protein, TAGRISSO cuts off these growth signals, slowing or stopping tumor growth and potentially shrinking existing tumors. It is specifically designed to target the most common EGFR-sensitizing mutations (exon 19 deletion and exon 21 L858R) as well as the T790M resistance mutation, while having less effect on normal EGFR in healthy cells.
The most common side effects of TAGRISSO, occurring in more than 1 in 10 patients, include diarrhea, skin and nail problems (rash, dry skin, itching, redness around nails), mouth sores (stomatitis), and decreased appetite. These are generally manageable with supportive care such as moisturizers for skin problems, anti-diarrheal medications, and gentle oral hygiene. Serious but less frequent side effects include interstitial lung disease, heart rhythm changes (QTc prolongation), and severe skin reactions. Always report any new or worsening symptoms to your healthcare team promptly.
Some medications can significantly interact with TAGRISSO. St. John’s wort must not be used at all with TAGRISSO. Strong CYP3A4 inducers such as phenytoin, carbamazepine, and rifampicin can dramatically reduce TAGRISSO’s effectiveness and should be avoided. Additionally, TAGRISSO may increase the blood levels of certain medications including rosuvastatin, dabigatran, digoxin, and aliskiren. Hormonal contraceptives may become less effective. Always tell your doctor about every medication, supplement, and herbal product you take so they can check for potential interactions.
TAGRISSO should not be used during pregnancy as it may harm the developing baby. Women of childbearing potential must use effective non-hormonal contraception during treatment and for at least 2 months after the last dose, since TAGRISSO may reduce the effectiveness of hormonal birth control. Men taking TAGRISSO should also use effective contraception during treatment and for 4 months afterward, as the drug may be present in semen. Breastfeeding is not recommended during TAGRISSO treatment. If you become pregnant during treatment, inform your doctor immediately.
The recommended dose of TAGRISSO is 80 mg taken orally once daily, with or without food. The tablet should be swallowed whole with water at the same time each day. If you experience certain side effects, your doctor may reduce the dose to 40 mg once daily. For patients who have difficulty swallowing, the tablet can be dispersed in approximately 50 ml of still water (do not use other liquids), stirred until it breaks into small pieces, and then drunk immediately. Rinse the glass with another 50 ml of water and drink that too.
References
- European Medicines Agency (EMA). TAGRISSO (osimertinib) – Summary of Product Characteristics. Last updated 2025.
- U.S. Food and Drug Administration (FDA). TAGRISSO (osimertinib) – Prescribing Information. Revised 2024.
- Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113–125. doi:10.1056/NEJMoa1713137 (FLAURA trial).
- Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020;382(1):41–50. doi:10.1056/NEJMoa1913662 (FLAURA OS data).
- Wu YL, Tsuboi M, He J, et al. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020;383(18):1711–1723. doi:10.1056/NEJMoa2027071 (ADAURA trial).
- Planchard D, Jänne PA, Cheng Y, et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023;389(21):1935–1948. doi:10.1056/NEJMoa2306434 (FLAURA2 trial).
- Lu S, Kato T, Dong X, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585–597. doi:10.1056/NEJMoa2401478 (LAURA trial).
- Mok TS, Wu YL, Ahn MJ, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017;376(7):629–640. doi:10.1056/NEJMoa1612674 (AURA3 trial).
- 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(6):495–529.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
Editorial Team
Medical Content
iMedic Medical Editorial Team – Specialists in Oncology and Clinical Pharmacology
Medical Review
iMedic Medical Review Board – Independent panel following WHO, EMA, FDA, and NCCN guidelines
Evidence Standard
Level 1A – Based on systematic reviews and meta-analyses of randomized controlled trials (GRADE framework)
Last Reviewed
– Content reviewed and updated according to latest clinical guidelines and prescribing information
All medical content on iMedic is created by healthcare professionals with relevant specialist qualifications. Content is independently reviewed, free from commercial influence, and follows international evidence-based medicine standards. We declare no conflicts of interest and receive no pharmaceutical industry funding. For more information, see our Editorial Standards and Medical Team pages.