The Committee for Medicinal Products for Human Use (CHMP) concluded that Vectibix’ s benefits are greater than its risks as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
Inimravimite komitee jõudis otsusele, et Vectibixi kasulikkus EGFR- positiivse, muteerumata (metsikut tüüpi) KRAS- geeniga metastaseerunud kolorektaalkartsinoomi monoteraapiaks patsientidel, kelle ravi fluoropürimidiini, oksaliplatiini ja irinotekaani sisaldavate keemiaravi skeemidega on ebaõnnestunud, on suurem kui ravimiga kaasnevad riskid.