Regulatory approval

Published by the European Medicines Agency. Approved

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 is written in the approval document as:

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	KRAS p.G12C	Non-Small Cell Lung Cancer	Adagrasib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2024-01-05	European Medicines Agency	Indication received approval from the European Commission.