# Lorlatinib

Lorlatinib (Lorviqua, Pfizer Europe MA EEIG) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (2).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ALK fusion | Monotherapy | 2nd line, advanced | 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 |
| ALK fusion | Monotherapy | Advanced | Previously not treated with an ALK inhibitor |

## Products

### Lorviqua

- Company: Pfizer Europe MA EEIG
- Target: ALK and ROS1 inhibitor
- Class: Anaplastic lymphoma kinase (ALK) inhibitors
- ATC: L01ED05
- EU approval: 6 May 2019
- Label revised: 3 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lorviqua-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lorviqua

Mechanism (SmPC section 5.1): Lorlatinib is an ATP-competitive tyrosine kinase inhibitor that selectively inhibits non-mutated ALK, clinically relevant ALK mutant kinases, and ROS1.

## Label wording

- **Lorlatinib** (Lorviqua), Non-small cell lung cancer, advanced: “Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf)
- **Lorlatinib** (Lorviqua), Non-small cell lung cancer, 2nd line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/lorlatinib