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Wednesday 2 November 2016


Osimertinib (previously known as mereletinib or AZD9291; trade name Tagrisso) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) drug, developed by AstraZeneca Pharmaceuticals – for mutated EGFR cancers.

In November 2015, after a Priority Review, the US FDA granted accelerated approval to osimertinib for the treatment of metastatic epidermal growth factor receptor EGFR-T790M mutation-positive non-small cell lung cancer (NSCLC ), as detected by an FDA-approved test, which has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

The FDA approval made reference to two clinical trials, in which an EGFR-T790M mutation was confirmed by a Cobas EGFR mutation test; osimertinib was given as 80 mg once daily.

The EU gave a similar approval in Feb 2016 after two Phase II studies (AURA extension and AURA2).

Osimertinib has also given encouraging results in early trials as a first-line therapy.

See also

- gefitinib

Open references

- Osimertinib making a breakthrough in lung cancer targeted therapy. Zhang H.
Onco Targets Ther. 2016 Sep 6;9:5489-93. doi : 10.2147/OTT.S114722. Review
PMID: 27660466