TAGRISSO (osimertinib), tyrosine kinase inhibitor
ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Mar 29 2017
Reason for request
No clinical benefit demonstrated in the treatment of locally-advanced or metastatic non-small cell lung cancer with EGFR T790M mutation
- TAGRISSO has Marketing Authorisation in the treatment of locally-advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR T790M mutation. This Marketing Authorisation is conditional on the results of a phase III comparative study (AURA3) in progress. The results of this study will be necessary to fully assess the extent of the effect and the role of osimertinib in the therapeutic strategy for NSCLC with EGFR T790M mutation.
- The only available data result from two non-comparative phase II studies performed in patients previously treated with anti-EGFR tyrosine kinase inhibitor (TKI).
- No data documents the safety and efficacy of osimertinib as a first-line treatment in patients carrying the T790M mutation from the outset (approximately 1% of cases).
Improvement in actual benefit
Évaluation des médicaments