Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized lorlatinib as a monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.

This is written in the approval document as:

Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.

Citation

Pfizer Europe MA EEIG. Lorviqua (lorlatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf. Revised January 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)	v::ALK	Non-Small Cell Lung Cancer	Lorlatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-05-06	European Medicines Agency	Indication received approval from the European Commission.