CHMP bad derfor indehaveren af markedsføringstilladelsen om yderligere at begrunde indikationen for Gemzar til kombinationsbehandling og som enkeltstof i forbindelse med NSCLC, idet det skal erindres, at enkeltstofbehandling sædvanligvis begrænses til patienter, hvis performance status er et grænsetilfælde, ældre patienter eller forbehandlede patienter.
The CHMP agreed that gemcitabine used as single agent has shown activity against NSCLC but considered that the combination treatment with gemcitabine + cisplatin is the first line of treatment in patients with advanced/metastatic NSCLC and therefore asked the MAH to further justify the indication of Gemzar as combination treatment and as single agent in NSCLC, bearing in mind that single-agent therapy will usually be restricted to patients with a borderline performance status, elderly patients or pretreated patients.