TAGRISSO approved by European Commission

AstraZeneca announced last week that TAGRISSO (Osimertinib) has been granted conditional marketing authorization by the European Commission (EC).

TAGRISSO is an 80mg tablet designed to be taken once a day to treat adults with locally progressed or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). It has received expedited approval from the EC, and is the first of its kind to be expedited.

Osimertinib was developed for patients with T790M mutation-positive NSCLC to replace other treatments previously received with an EGFR tyrosine Kinase inhibitor (TKI). A diagnostic test conducted on tumor tissue sample or plasma to define mutation status will be the basis to determine whether or not osimertinib will be eligible to be used in treatments.

EGFR receptor mutation can lead to unrestrained cell growth and the formation of tumors. This triggers the development of cancer. The T790M mutation creates a resistance in tumors to existing treatments with EGFR-TKIs. Osimertinib targets mutations in the EGFR receptor and the T790 mutation. Almost two out of every three patients whose NSCLC has further developed after an EGFR inhibitor treatment saw the development of the T790M mutation. Osimertinib, if approved, will provide a way to combat this.