Update as of 27 July 2023:
The applicant for Krazati has requested a re-examination of EMA’s July 2023 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its recommendation and issue a final recommendation.
The European Medicines Agency has recommended the refusal of the conditional marketing authorisation for Krazati, a medicine intended for treating advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
The Agency issued its opinion on 20 July 2023. The company that applied for authorisation, Mirati Therapeutics B.V., may ask for re-examination of the opinion within 15 days of receiving the opinion.
|Agency product number||
|International non-proprietary name (INN) or common name||
Carcinoma, Non-Small-Cell Lung
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
|Date opinion adopted||