Krazati

Krazati was developed as a medicine for treating adults with advanced non-small cell lung cancer (NSCLC) when the cancer cells have a particular genetic change (mutation) known as KRAS G12C. It was intended for patients who had already tried at least one systemic treatment (a treatment affecting the whole body).

Krazati contains the active substance adagrasib and was to be available as tablets.

Genetic changes to the KRAS gene can produce an altered protein that causes the uncontrolled growth of cancer cells. The active substance in Krazati, adagrasib, attaches to this altered protein inside cancer cells, making the protein inactive and thereby slowing the growth and spread of the cells. It also encourages processes that kill the cancer cells.

The company presented results from a main study involving 116 adults with advanced NSCLC with a KRAS G12C mutation who had received at least one systemic treatment. The study looked at the number of patients whose cancer responded partially or completely to treatment and did not compare Krazati to any other treatment.

The Agency’s human medicines committee (CHMP) noted that comprehensive data for this medicine were not yet available and that there were uncertainties about how well the medicine worked.

Although the company applied for a conditional marketing authorisation, the medicine did not meet the criteria for granting this type of authorisation. The company could not show that Krazati fulfils an unmet need and could not justify making the medicine immediately available to patients while further data were still awaited. The Agency therefore recommended refusing the conditional marketing authorisation.

The company informed the Agency that there are no consequences for patients in clinical trials or in compassionate use programmes with Krazati.

If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.