TAGRISSO (osimertinib), tyrosine kinase inhibitor
ONCOLOGY - Update
Opinions on drugs - Posted on Apr 12 2018
Reason for request
Re-assessment of the improvement in actual benefit
Substantial actual benefit and minor improvement compared with chemotherapy combining a platinum salt with pemetrexed in patients who acquired the EGFR T790M mutation during a previous treatment with anti-EGFR TKI.
- TAGRISSO has Marketing Authorisation in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR T790M mutation.
- The new data affect only patients who acquired the EGFR T790M mutation during their first-line treatment with anti-EGFR TKI.
- In this case, progression-free survival was improved compared with platinum-based chemotherapy (absolute gain of 5.7 months) in patients previously treated with an anti-EGFR TKI.
- No gain in overall survival has been demonstrated to date.
- The safety profile of osimertinib is more favourable than that of platinum salt-based chemotherapy.
Clinical Added Value
Évaluation des médicaments
HAS opinions and decisions