Indikationen understøttes af en klinisk ekspertrapport og effektdata fra fase II - og fase III- undersøgelser med Gemzar som enkeltstof til behandling af brystcancer, herunder undersøgelser foretaget af indehaveren af markedsføringstilladelsen og resultater fra offentliggjort litteratur.
Regarding breast cancer, the MAH only proposed combination use for inclusion in the harmonised SPC, although a Phase 3 study showed the activity of single-agent gemcitabine for the treatment of metastatic breast cancer (MBC). The indication was supported by a clinical expert report and efficacy data from Phase 2 and 3 single-agent studies of Gemzar in the treatment of breast cancer, including studies conducted by the MAH and results from the published literature.