# ALK

25 EU-approved indications of 13 drugs need a ALK result, in 3 tumour types, most of them in non-small cell lung cancer, T-cell lymphoma and other musculoskeletal tumours.

## Approved indications by tumour

### Non-small cell lung cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | EGFR/ALK negative | + platinum-based chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| [Alectinib](https://oncolabels.com/drugs/alectinib) (Alecensa) | ALK fusion | Monotherapy | Adjuvant | After complete tumour resection; High risk of recurrence |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | EGFR/ALK negative | Monotherapy | Adjuvant, early | After neoadjuvant durvalumab + platinum-based chemotherapy and surgical resection; High risk of recurrence |
| [Alectinib](https://oncolabels.com/drugs/alectinib) (Alecensa) | ALK fusion | Monotherapy | 1st line, advanced | - |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | EGFR/ALK-negative | + bevacizumab, paclitaxel and carboplatin | 1st line, metastatic | Non-squamous only |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | EGFR/ALK-negative | + nab-paclitaxel and carboplatin | 1st line, metastatic | Non-squamous only |
| [Ceritinib](https://oncolabels.com/drugs/ceritinib) (Zykadia) | ALK fusion | Monotherapy | 1st line, advanced | - |
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ALK fusion | Monotherapy | 1st line, advanced | - |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | No sensitising EGFR mutations or ALK positive mutations | + tremelimumab and platinum-based chemotherapy | 1st line, metastatic | - |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | No sensitising EGFR mutation or ALK translocation | + nivolumab and 2 cycles of platinum-based chemotherapy | 1st line, metastatic | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | No sensitising EGFR mutation or ALK translocation | + ipilimumab and 2 cycles of platinum-based chemotherapy | 1st line, metastatic | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | EGFR/ALK-negative | + pemetrexed and platinum chemotherapy | 1st line, metastatic | Non-squamous only |
| [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) |
| [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 | - |
| [Tremelimumab](https://oncolabels.com/drugs/tremelimumab) (Imjudo) | No sensitising EGFR mutations or ALK positive mutations | + durvalumab and platinum-based chemotherapy | 1st line, metastatic | - |
| [Alectinib](https://oncolabels.com/drugs/alectinib) (Alecensa) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | ALK fusion | + bevacizumab, paclitaxel and carboplatin | 2nd line, metastatic | Non-squamous only; After failure of appropriate targeted therapies |
| [Brigatinib](https://oncolabels.com/drugs/brigatinib) (Alunbrig) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| [Ceritinib](https://oncolabels.com/drugs/ceritinib) (Zykadia) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated |
| [Lorlatinib](https://oncolabels.com/drugs/lorlatinib) (Lorviqua) | 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 |
| [Brigatinib](https://oncolabels.com/drugs/brigatinib) (Alunbrig) | ALK fusion | Monotherapy | Advanced | No prior ALK inhibitor |
| [Lorlatinib](https://oncolabels.com/drugs/lorlatinib) (Lorviqua) | ALK fusion | Monotherapy | Advanced | Previously not treated with an ALK inhibitor |

### T-cell lymphoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ALK fusion | Monotherapy | 2nd line | Systemic ALCL only; Children and adolescents only; Relapsed or refractory; Age ≥ 1 to < 18 years |

### Other musculoskeletal tumours

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ALK fusion | Monotherapy | 2nd line, advanced | Children and adolescents only; Recurrent or refractory; Age ≥ 1 to < 18 years |

## Label wording

- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 1st line, metastatic: “KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, 1st line, metastatic: “OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-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)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, neoadjuvant, early: “IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, adjuvant, early: “IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, 1st line, metastatic: “IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-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, 1st line, advanced: “The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, 2nd line, advanced: “The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), T-cell lymphoma, 2nd line: “The treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Other musculoskeletal tumours, 2nd line, advanced: “The treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, metastatic: “In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **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)
- **Ipilimumab** (Yervoy), Non-small cell lung cancer, 1st line, metastatic: “YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, adjuvant: “Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, 1st line, advanced: “Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, 2nd line, advanced: “Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Tremelimumab** (Imjudo), Non-small cell lung cancer, 1st line, metastatic: “IMJUDO in combination with durvalumab and 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 positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf)
- **Ceritinib** (Zykadia), Non-small cell lung cancer, 1st line, advanced: “Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf)
- **Ceritinib** (Zykadia), Non-small cell lung cancer, 2nd line, advanced: “Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf)
- **Brigatinib** (Alunbrig), Non-small cell lung cancer, advanced: “Alunbrig is indicated as monotherapy 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/alunbrig-epar-product-information_en.pdf)
- **Brigatinib** (Alunbrig), Non-small cell lung cancer, 2nd line, advanced: “Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alunbrig-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/biomarkers/alk