Tagrisso (osimertinib)

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Tagrisso (osimertinib)

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


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:

  • as first-line treatment of patients whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations1,8.

  • as second line treatment of patients whose disease has progressed on or after EGFR TKI therapy1,2,3.

How does Tagrisso (osimertinib) work?

The activity of the epidermal growth factor receptor (EGFR) normally controls growth and division of cells. In lung cancer cells, the EGFR is often overactive, causing uncontrolled division of cancer cells. By blocking the 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 approval  (second-line treatment)5

    • March 30, 2017, with regular approval  (second-line treatment)6

    • April 18, 2018, as a first line treatment7

  • European Medical Agency (EMA), European Union: 

    • February 2, 2016  (second-line treatment)4
    • June 11, 2018 (first-line treatment)8
  • Therapeutic Goods Administration (TGA), Australia, August 3, 2016  (second line treatment)3

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 or adverse reactions of Tagrisso (osimertinib)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include1:

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

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1:

  • interstitial lung disease (ILD)/pneumonitis
  • pneumonia
  • heart rate disturbances (QTc Interval Prolongation)
  • cardiomyopathy
  • keratitis (inflammation of the cornea of the eye).

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. Men are advised to use effective contraception for 4 months, after the last dose1. Do not breastfeed1.

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 Controlled room temperature (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

First-line treatment approval

The Food and Drug Administration (FDA), USA, approval of Tagrisso (osimertinib) for EGFR positive lung cancer in previously untreated patients were based on a randomized, multicenter, double-blind, active-controlled trial (FLAURA [NCT02296125]). This study involved a total of 556 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive, metastatic NSCLC, who had not received previous systemic treatment for metastatic disease. Patients were divided in groups; 279 of them received either Tagrisso (osimertinib) 80 mg orally once daily; 183 received gefitinib 250 mg orally once daily; and 94 received erlotinib 150 mg orally once daily until disease progression or unacceptable toxicity. Patients continued treatment until disease progression or unacceptable toxicity1.

Results

Among the efficacy outcome measures 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)1.

The study demonstrated a significant improvement in PFS for patients who took Tagrisso (osimertinib) compared to those who took erlotinib or gefitinib1.

The median PFS was1:

  • 18.9 months [95 % CI: 15.2, 21.4] with Tagrisso (osimertinib) vs. 10.2 [95 % CI: 4.2, 5.6] with erlotinib or gefitinib.

The ORR was1:

  • 77% [95% CI: 71, 82] with Tagrisso (osimertinib) vs 69% [95% CI: 63, 74] with erlotinib or gefitinib.
    • Complete responses: 2% vs. 1%.

The median DOR was1:

  • 17.6 months [95 % CI: 13.8, 22.0] with Tagrisso (osimertinib) vs. 9.6 [95 % CI: 8.3, 11.1] with erlotinib or gefitinib.

The CNS-ORR was1:

  • 77% [95% CI: 55, 92] with Tagrisso vs 63% [95% CI: 38, 84] with erlotinib or gefitinib. 

The CNS-DOR was1:

  • equal or above 6 months in 88% of patients on Tagrisso (osimertinib) vs. 50% of patients on erlotinib or gefitinib. 
  • equal or above 12 months in 47% of patients on Tagrisso (osimertinib) vs. 33% of patients on erlotinib or gefitinib.

Second-line treatment approval

Approvals by the Food and Drug Administration (FDA), European Medical Agency (EMA) and Therapeutic Goods Administration (TGA), 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) also refer 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 therapy1.

Results

Among the efficacy outcome measures in AURA3 were progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR). The response of brain metastases was also monitored (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 Controlled room temperature (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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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.