What is Tagrisso (osimertinib) for?

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

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

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

It is available in tablet form each containing 40mg or 80mg osimertinib mesylate.1,2,3

How does Tagrisso (osimertinib) work?

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. Tagrisso (osimertinib) is a targeted therapy that works specifically on the EGFR. Targeted therapies are not chemotherapy or immunotherapy.

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 gene.4

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

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  Health Canada, July 19, 2016 (first- and second-line treatment)9

• Therapeutic Goods Administration (TGA), Australia, August 3, 2016 (second-line treatment)3

• Medsafe (New Zealand), October 5, 2017 (first-line treatment)10

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 for assistance.

We have supported patients from various countries access Tagrisso with success. The majority of our patients who have requested access to this medicine come from:

• India
• United Kingdom
• Pakistan
• Malaysia
• Philippines
• Bangladesh

How is Tagrisso (osimertinib) taken?

The standard dosage is:

• 80 mg tablets orally once daily

When a patient suffers from adverse reactions, it may be decided to lower the dosage to 40 mg once daily or pause or stop treatment permanently.

You may have noticed that the price of 40mg tablets and 80mg tablets do not vary much. This has been decided by the manufacturer and suppliers to equalise the daily cost of treatment between patients who require either a low dose and patients requiring a high dose.

Complete information about Tagrisso (osimertinib) dosage (modifications) 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

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Tagrisso (osimertinib) can be fatal for a fetus, it is advised to avoid pregnancy 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.

References

1. Summary of Product Characteristics [FDA]: Tagrisso (osimertinib) [PDF] Manufacturer: AstraZeneca, Oct. 2017.

2. Summary of Product Characteristics [EMA]: Tagrisso (osimertinib) [PDF] AstraZeneca, Sep. 2017.

3. Summary of Product Characteristics [TGA]: Tagrisso (osimertinib) [PDF] AstraZeneca, Dec. 2016.

4. EMA. Human Medicines: Tagrisso (osimertinib) cited June 2017

5. FDA News Release: FDA approves new pill to treat certain patients with non-small cell lung cancer Nov 2015

6. FDA. Approved Drugs: Tagrisso (osimertinib) cited June 2017

7. FDA. Approved Drugs. FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations 19/04/2018.

8. EU approves first-line use of AZ’ Tagrisso in lung cancer PharmaTimes, 11/06/2018.

9. Product monograph [Health Canada]: Tagrisso (osimertinib) [PDF] AstraZeneca, Jul. 2016.

10. Product detail [Medsafe]: Tagrisso (osimertinib)AstraZeneca, Jan. 2020.

For more information please visit our blog page “What is Tagrisso?”

Source: https://t-tees.com
Category: WHY