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 Benefit



Clinical Added Value



Therapeutic use




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