Reason for request

Modification of indication

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Clinical Benefit

Substantial

Substantial


Clinical Added Value

no clinical added value

The modification of indication for VECTIBIX, restricting its use to patients with wild-type RAS (KRAS and NRAS) metastatic colorectal cancer within the framework of a stratified strategy, does not change the Transparency Committee's previous assessments in the absence of comparative data versus other biotherapies indicated in these patients in the various lines of treatment.

Consequently, and given the current state of the data, VECTIBIX does not provide any improvement in actual benefit (level V, non-existent) in the treatment of wild-type RAS metastatic colorectal cancer :
- in first-line therapy in combination with FOLFOX
- in second-line therapy in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)
- in monotherapy after failure of fluoropyrimidine-,oxaliplatin-, and irinotecan-containing chemotherapy regimens.


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