KRAZATI (adagrasib) - Advanced non-small cell lung cancer

The Committee deems that the clinical benefit of KRAZATI 200 mg (adagrasib) film-coated tablets is low in the MA indication.

Considering:

KRAZATI (adagrasib) demonstrated a statistically significant superiority in terms of progression-free survival and objective response rate assessed by an independent review committee in a randomised, open-label phase 3 study versus docetaxel.

However, this result is limited by:

• the lack of clinical relevance of the absolute difference in progression-free survival medians, of 1,65 month;
• the open-label implementation of the study, having led to possible assessment biases, particularly in terms of treatment decisions;
• the lack of evidence of an effect on overall survival, in a context of advanced disease with an unfavourable prognosis;
• the lack of clinical relevance of the objective response rate in this context;
• the absence of any formal conclusion that can be drawn based on the quality of life findings;
• the safety profile of adagrasib, which does not appear to be more favourable than that of docetaxel;

the Committee deems that KRAZATI 200 mg (adagrasib) film-coated tablets provides no clinical added value (CAV V) compared with docetaxel.