Tagrisso (osimertinib)

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Tagrisso (osimertinib)

Tagrisso (osimertinib) is a medicine for the treatment of patients with a metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC).

How to buy Tagrisso (osimertinib): You can order Tagrisso (osimertinib) from TheSocialMedwork if the drug has not been approved or is not available in your country.

Oncology Lung Cancer
Marketing Authorisation Holder AstraZeneca AB
Mode of Action Kinase inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Package 30 Tablets

What is Tagrisso (osimertinib) for?

Tagrisso (osimertinib) is a kinase inhibitor indicated for the treatment of patients with a specific type of lung cancer (metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC))1,2,3.

How does Tagrisso (osimertinib) work?

The activity of epidermal growth factor receptor (EGFR) normally controls growth and division of cells. In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells. By blocking EGFR, osimertinib helps to reduce the growth and spread of the cancer. Unlike most other tyrosine kinase inhibitors, Tagrisso (osimertinib) is active against cancer cells with the T790M mutation in the EGFR gene4.

Where has Tagrisso (osimertinib) been approved?

Tagrisso (osimertinib) has been approved for advanced or metastatic NSCLC in patients with epidermal growth factor receptor (EGFR) T790M mutation by the following regulatory agencies in the following regions:

  • Food and Drug Administration (FDA), USA:

    • November 13, 2015, with accelerated approval5

    • March 30, 2017, with regular approval6

  • European Medical Agency (EMA), European Union, February 2, 20164

  • Therapeutic Goods Administration (TGA), Australia, August 3, 20163

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Tagrisso (osimertinib) taken?

The standard dosage is:

  • 80 mg orally once daily

Complete information about Tagrisso (osimertinib) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Tagrisso (osimertinib)?

Common side effects

The most common side effects listed in the prescribing information include:

  • diarrhea
  • rash
  • dry skin
  • nail
  • toxicity
  • fatigue.

Serious side effects

The serious side effects listed in the prescribing information include:

  • interstitial Lung Disease (ILD)/Pneumonitis
  • pneumonia
  • heart rate disturbances (QTc Interval Prolongation)
  • cardiomyopathy
  • keratitis (inflammation of the cornea of the eye)
  • renal insufficiency.

Use in a specific population

Tagrisso (osimertinib) can be fatal for a fetus, it is advised to avoid pregnancies during treatment and for 6 weeks after the final dose. Advise males to use effective contraception for 4 months, after the last dose. Do not breastfeed.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.

More Information
Working ingredient osimertinib
Shipping method Standard (not temperature controlled)
Package 30
Therapeutic Area Oncology
Oncology Lung Cancer
Indication Advanced or metastatic NSCLC with T790M mutation
Administration Oral
Mode of Action Kinase inhibitor (chemotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder AstraZeneca AB
HS Code 30049000
CAS Number 1421373-65-0

The Food and Drug Administration (FDA), European Medical Agency (EMA), Therapeutic Goods Administration (TGA), approvals of Tagrisso (osimertinib) for T790M mutation positive NSCLC in previously treated patients (2nd line treatment) were based on 2 single-arm, open-label clinical trials (AURAex and AURA2). These studies involved a total of 411 patients who had progressed on one or more prior systemic therapies (2nd line treatment). The Food and Drug Administration (FDA) and European Medical Agency (EMA) refer also to a third study (AURA3) in which Tagrisso (osimertinib) was tested against platinum-based chemotherapy. This study involved 419 patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy.


Among the efficacy outcome measures in AURA3 were the progression-free survival (PFS), objective response rate (ORR), duration of response (DOR). The response of brain metastases was monitored as well (CNS-ORR, CNS-DOR). The major efficacy outcome measure in AURAex and AURA2 was the Objective Response Rate (ORR).

The efficacy of Tagrisso (osimertinib) was demonstrated in all 3 studies.

The median PFS was:

  • 10.1 months [95 % CI: 8.3,12.3] with Tagrisso vs. 4.4 [95 % CI: 4.2, 5.6] with chemotherapy in AURA32.

The ORR was:

  • 71% [95% CI: 65, 76] with Tagrisso vs 31% [95% CI: 24, 40] with chemotherapy in AURA32

  • 62% [95% CI: 55, 68] in AURAex2

  • 70% [95 % CI: 63, 77] in AURA22.

The median DOR was:

  • 9.7 months [95 % CI: 8.3,11.6] with Tagrisso vs. 4.1 [95 % CI: 3.0, 5.6] with chemotherapy in AURA32.

The CNS-ORR was:

  • 70% [95% CI: 51%,85%] with Tagrisso vs 31% [95% CI: 11%,59%]with chemotherapy in AURA32.

The median CNS-DOR was:

  • 8.9 months [95 % CI: 4.3, N.C.] with Tagrisso vs. 5.7 [95 % CI: N.C.,N.C.] with chemotherapy in AURA32.

Shipping Type Standard
Shipping method Standard (not temperature controlled)
Dynamic Weight No
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For prescription medicines you will always need a prescription from your treating doctor. This is to ensure that your treatment is monitored and led by a doctor who is responsible for administering the medicine to you. The prescription is the evidence that your doctor gives you their medical support.
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By using TheSocialMedwork you will receive genuine medicines in perfect condition, no matter where you live.
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.