KRAZATI (adagrasib) - Advanced non-small cell lung cancer
Opinions on drugs -
Posted on
Mar 19 2025
Reason for request
Initial inclusion
Summary of opinion
Favourable opinionfor reimbursement in “KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.”
Clinical Benefit
Low
The Committee deems that the clinical benefit of KRAZATI 200 mg (adagrasib) film-coated tablets is low in the MA indication.
Clinical Added Value
no clinical added value
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.
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