The clinical evidence was derived from a multi-centred,
open-label, randomized phase III study (PRIMA) comparing
first-line maintenance treatment with RTX with
observation only in 1,018 patients with previously untreated
advanced fNHL. Median time to event (MTE) for the primary
endpoint of progression-free survival (PFS) in theRTXarmwas
not estimable due to data immaturity; median PFS in the
observation arm was 48.36 months.