Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that KRAS p.G12C status confers therapeutic sensitivity to Adagrasib in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized adagrasib as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS p.G12C variant and disease progression after at least one prior systemic therapy.

This statement is based on a regulatory approval from the European Medicines Agency:

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.

Citation

Mirati Therapeutics B.V. Krazati (adagrasib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/krazati-epar-product-information_en.pdf. Revised March 2024. Accessed March 19, 2024.