EGFR in non-small cell lung cancer
31 EU-approved indications in non-small cell lung cancer need a EGFR result: pembrolizumab (1st line, metastatic), nivolumab (1st line, metastatic), sugemalimab (1st line, metastatic), dacomitinib (1st line, advanced), gefitinib (advanced), durvalumab (neoadjuvant, early), durvalumab (adjuvant, early), durvalumab (1st line, metastatic), lazertinib (1st line, advanced), serplulimab (1st line, advanced), bevacizumab (1st line, advanced), osimertinib (adjuvant), osimertinib (consolidation, locally advanced), osimertinib (1st line, advanced), osimertinib (advanced), osimertinib (1st line, advanced), atezolizumab (1st line, metastatic), atezolizumab (2nd line, metastatic), atezolizumab (1st line, metastatic), amivantamab (1st line, advanced), amivantamab (2nd line, advanced), amivantamab (1st line, advanced), amivantamab (2nd line, advanced), ipilimumab (1st line, metastatic), afatinib (advanced), tremelimumab (1st line, metastatic), ramucirumab (1st line, metastatic), erlotinib (1st line, advanced), erlotinib (maintenance, advanced), erlotinib (2nd line, advanced) and erlotinib (2nd line, advanced).
Histology
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EGFR mutation19 | ||||
Tagrisso | Exon 19 deletions or exon 21 (L858R) | Monotherapy | Adj. | After complete tumour resection; Stage IB-IIIA |
Rybrevant | Exon 20 insertion | + carboplatin and pemetrexed | 1L advanced | None |
Rybrevant | Exon 19 deletions or exon 21 L858R | + lazertinib | 1L advanced | None |
Avastin | + erlotinib | 1L advanced | Non-squamous only | |
Vizimpro | EGFR-activating mutation | Monotherapy | 1L advanced | None |
Tarceva | Monotherapy | 1L advanced | None | |
Lazcluze | Exon 19 deletions or exon 21 L858R | + amivantamab | 1L advanced | None |
Tagrisso | Exon 19 deletions or exon 21 (L858R) | + pemetrexed and platinum-based chemotherapy | 1L advanced | None |
Tagrisso | Monotherapy | 1L advanced | None | |
Cyramza | + erlotinib | 1L metastatic | None | |
Tarceva | Monotherapy | Maint. advanced | Stable disease after first-line chemotherapy | |
Tagrisso | Exon 19 deletions or exon 21 (L858R) | Monotherapy | Consol. locally adv. | After platinum-based chemoradiation therapy without disease progression; Unresectable; disease has not progressed during or following platinum-based chemoradiation therapy |
Rybrevant | Exon 19 deletions or exon 21 L858R | + carboplatin and pemetrexed | 2L advanced | After failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI) |
Rybrevant | Exon 20 insertion | Monotherapy | 2L advanced | After failure of platinum-based therapy |
Tecentriq | + bevacizumab, paclitaxel and carboplatin | 2L metastatic | Non-squamous only; After failure of appropriate targeted therapies | |
Tarceva | Monotherapy | 2L advanced | After failure of at least one prior chemotherapy regimen | |
Giotrif | Activating EGFR mutation(s) | Monotherapy | Any line advanced | EGFR TKI-naïve |
Iressa | Activating mutations of EGFR-TK | Monotherapy | Any line advanced | None |
Tagrisso | T790M | Monotherapy | Any line advanced | None |
| EGFR negative1 | ||||
Tarceva | Monotherapy | 2L advanced | After failure of at least one prior chemotherapy regimen; When other treatment options are not considered suitable | |
| EGFR/ALK negative9 | ||||
Imfinzi | + platinum-based chemotherapy | Neoadj. early | Then adjuvant monotherapy after surgery; High risk of recurrence | |
Imfinzi | Monotherapy | Adj. early | After neoadjuvant durvalumab + platinum-based chemotherapy and surgical resection; High risk of recurrence | |
Tecentriq | EGFR/ALK-negative | + bevacizumab, paclitaxel and carboplatin | 1L metastatic | Non-squamous only |
Tecentriq | EGFR/ALK-negative | + nab-paclitaxel and carboplatin | 1L metastatic | Non-squamous only |
Imfinzi | No sensitising EGFR mutations or ALK positive mutations | + tremelimumab and platinum-based chemotherapy | 1L metastatic | None |
Yervoy | No sensitising EGFR mutation or ALK translocation | + nivolumab and 2 cycles of platinum-based chemotherapy | 1L metastatic | None |
Opdivo | No sensitising EGFR mutation or ALK translocation | + ipilimumab and 2 cycles of platinum-based chemotherapy | 1L metastatic | None |
Keytruda | EGFR/ALK-negative | + pemetrexed and platinum chemotherapy | 1L metastatic | Non-squamous only |
Imjudo | No sensitising EGFR mutations or ALK positive mutations | + durvalumab and platinum-based chemotherapy | 1L metastatic | None |
| EGFR/ALK/ROS1 negative1 | ||||
Hetronifly | + carboplatin and pemetrexed | 1L advanced | Non-squamous only; Not candidates for surgery or radiotherapy (if locally advanced) | |
| EGFR/ALK/ROS1/RET negative1 | ||||
Cejemly | No sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | + platinum-based chemotherapy | 1L metastatic | None |
16 approvals for NSCLC need no biomarker and apply whatever the result. All approvals for NSCLC
See also
Label wording31
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
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.
- Nivolumab (Opdivo)
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.
- Sugemalimab (Cejemly)
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.
- Dacomitinib (Vizimpro)
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
- Gefitinib (Iressa)
IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
- Durvalumab (Imfinzi)
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).
- Durvalumab (Imfinzi)
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).
- Durvalumab (Imfinzi)
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.
- Lazertinib (Lazcluze)
Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
- Serplulimab (Hetronifly)
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.
- Bevacizumab (Avastin)
Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).
- Osimertinib (Tagrisso)
the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1).
- Osimertinib (Tagrisso)
the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
- Osimertinib (Tagrisso)
the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.
- Osimertinib (Tagrisso)
the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
- Osimertinib (Tagrisso)
pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
- Atezolizumab (Tecentriq)
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).
- Atezolizumab (Tecentriq)
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).
- Atezolizumab (Tecentriq)
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).
- Amivantamab (Rybrevant)
in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.
- Amivantamab (Rybrevant)
in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
- Amivantamab (Rybrevant)
in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations.
- Amivantamab (Rybrevant)
as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.
- Ipilimumab (Yervoy)
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.
- Afatinib (Giotrif)
Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
- Tremelimumab (Imjudo)
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.
- Ramucirumab (Cyramza)
Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (see section 5.1).
- Erlotinib (Tarceva)
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.
- Erlotinib (Tarceva)
Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.
- Erlotinib (Tarceva)
Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
- Erlotinib (Tarceva)
In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.