|| Lung Cancer
|| Advanced or metastatic NSCLC with T790M mutation
| Mode of Action
|| Kinase inhibitor (targeted therapy)
| Approval Status
|| EMA approved (EU); FDA approved (USA); TGA approved (AUS)
| CAS Number || 1421373-65-0
| HS Code
|| 40 mg, 80 mg
Who is osimertinib for?
Tagrisso (osimertinib) is indicated for the treatment of advanced or metastatic NSCLC in patients with epidermal growth factor receptor (EGFR) T790M mutation .
Complete information about Tagrisso (osimertinib) dosage and administration can be found here .The standard dosage is:
Consult your treating doctor for personalised dosing.
What is osimertinib and how does it work?
Tagrisso (osimertinib) is a kinase inhibitor indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC) 
It blocks the activity of EGFR, which 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 gene 
What is osimertinib's approval status?
Tagrisso (osimertinib) was approved by:
for the treatment of metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC). The approvals of osimertinib for T790M mutation positive NSCLC were based on two single-arm, open-label clinical studies, AURAex (Phase II Extension cohort, (n=201)) and AURA2 (n=210) involving patients who had progressed on one or more prior systemic therapies .In the 411 pre-treated EGFR T790M mutation-positive patients, the total overall response rate (ORR) was 66 % [95 % CI: 61, 71] — 62 % [95 % CI: 55, 68] in AURAex and 70 % [95 % CI: 63, 77] in AURA2. In patients with a confirmed response the median duration of response (DoR) was 12.5 months [95 % CI: 11.1, non estimable]. The medianprogression free survival (PFS) was 11.0 months [95 % CI (9.6, 12.4] .
- FDA (USA) on November 13, 2015  with accelerated approval and on March 30, 2017  with regular approval
- EMA (EU) on February 2, 2016 
- TGA (AUS) on August 3, 2016 
A third study (AURA3) involved 419 patients and compared the efficacy of Tagrisso (osimertinib) in preventing the cancer from worsening, comparing it with a platinum-based chemotherapy (the standard treatment for NSCLC). In patients taking Tagrisso, the PFS was 10.1 months compared with 4.4 months in patients on chemotherapy. There were no significant differences in overall survival. The objective response rate was 71 % [95 % CI: 65, 76] in patients taking osimertinib and 31 % [95 % CI: 24, 40] in patients on standard chemotherapy. The duration of response was 9.7 months [95 % CI: 8.3, 11.6] on osimertinib vs 4.1 months [95 % CI: 3.0, 5.6] 
The most common side effects are diarrhoea, rash, dry skin, paronychia (nail infection), itching, stomatitis (inflammation of the lining of the mouth) and a decrease in the levels of white blood cells and platelets 
Summary of Product Characteristics [FDA]: Tagrisso (osimertinib), AstraZeneca, Mar. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf
Summary of Product Characteristics [EMA]: Tagrisso (osimertinib), AstraZeneca, May 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004124/WC500202022.pdf
Summary of Product Characteristics [TGA]: Tagrisso (osimertinib), AstraZeneca, Dec. 2016. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-02334-1
EMA. Human Medicines: Tagrisso (osimertinib), 17/02/2016 (last update: 02/03/2016), cited on 20/06/2017. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004124/human_med_001961.jsp&mid=WC0b01ac058001d124
FDA News Release: FDA approves new pill to treat certain patients with non-small cell lung cancer, 13/11/2015. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm472525.htm
FDA. Approved Drugs: Tagrisso (osimertinib), 30/03/2017, cited on 20/06/2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm549683.htm
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