KRAS

8 EU-approved indications of 4 drugs need a KRAS result, in 2 tumour types, most of them in colorectal cancer and non-small cell lung cancer.

Approved indications8

DrugBiomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
Adagrasib
Krazaticonditional
G12C
Monotherapy
2L
advanced
Disease progression after at least one prior systemic therapy
Sotorasib
Lumykrasconditional
G12C
Monotherapy
2L
advanced
After at least one prior line of systemic therapy
Colorectal cancer6
Cetuximab
Erbitux
RAS wild-type, EGFR-expressing
+ FOLFOX
1L
metastatic
None
Panitumumab
Vectibix
Wild-type RAS
+ FOLFOX or FOLFIRI
1L
metastatic
None
Panitumumab
Vectibix
Wild-type RAS
+ FOLFIRI
2L
metastatic
After first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)
Cetuximab
Erbitux
RAS wild-type, EGFR-expressing
Monotherapy
3L+
metastatic
Failed oxaliplatin- and irinotecan-based therapy; Intolerant to irinotecan
Panitumumab
Vectibix
Wild-type RAS
Monotherapy
3L+
metastatic
Failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens
Cetuximab
Erbitux
RAS wild-type, EGFR-expressing
+ irinotecan-based chemotherapy
Any line
metastatic
None

KRAS by tumour

Label wording8

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Adagrasib (Krazati)
    KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.
  2. Sotorasib (Lumykras)
    LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and who have progressed after at least one prior line of systemic therapy.
  3. Cetuximab (Erbitux)
    Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy,
  4. Cetuximab (Erbitux)
    Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX,
  5. Cetuximab (Erbitux)
    Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX, • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
  6. Panitumumab (Vectibix)
    in first-line in combination with FOLFOX or FOLFIRI.
  7. Panitumumab (Vectibix)
    in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  8. Panitumumab (Vectibix)
    as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.