# ROS1 in non-small cell lung cancer

5 EU-approved indications in non-small cell lung cancer need a ROS1 result: entrectinib (advanced), sugemalimab (1st line, metastatic), serplulimab (1st line, advanced), crizotinib (advanced) and repotrectinib (advanced).

## Approved indications

### ROS1 fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ROS1 fusion | Monotherapy | Advanced | - |
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | ROS1 fusion | Monotherapy | Advanced | No prior ROS1 inhibitor |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | ROS1 fusion | Monotherapy | Advanced | - |

### EGFR/ALK/ROS1 negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Serplulimab](https://oncolabels.com/drugs/serplulimab) (Hetronifly) | EGFR/ALK/ROS1 negative | + carboplatin and pemetrexed | 1st line, advanced | Non-squamous only; Not candidates for surgery or radiotherapy (if locally advanced) |

### EGFR/ALK/ROS1/RET negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Sugemalimab](https://oncolabels.com/drugs/sugemalimab) (Cejemly) | No sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | + platinum-based chemotherapy | 1st line, metastatic | - |

## Label wording

- **Entrectinib** (Rozlytrek), Non-small cell lung cancer, advanced: “Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf)
- **Sugemalimab** (Cejemly), Non-small cell lung cancer, 1st line, metastatic: “Cejemly in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Non-small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have:
 locally advanced NSCLC who are not candidates for surgery or radiotherapy, or  metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, advanced: “The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Repotrectinib** (Augtyro), Non-small cell lung cancer, advanced: “AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/augtyro-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/tumours/non-small-cell-lung-cancer/ros1