Tagrisso (osimertinib)

Description

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 mutations^[1,8].
• as second line treatment of patients whose disease has progressed on or after EGFR TKI therapy^[1,2,3].

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 treatment^[7]
• European Medical Agency (EMA), European Union:
  • February 2, 2016 (second-line treatment)^[4]
  • June 11, 2018 (first-line treatment)^[8]
• 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.