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Conclusions on clinical efficacy (EPAR)
Physicians should consider the delayed onset of nivolumab effect before
initiating treatment in patients with poorer prognostic features and/or
aggressive disease. In non-squamous NSCLC, a higher number of
deaths within 3 months was observed in nivolumab compared to
docetaxel.
Factors associated with early deaths were poorer
prognostic factors and/or more aggressive disease combined
with low or no tumour PD-L1 expression
(see sections 4.4 and 5.1
of the SmPC).
Ficha técnica de Nivolumab_AEMPS_Mayo 2016
FT Novolumab_Opdivo, AEMPS, pag 7
European Public Assessment Report , EMA/246304/2016, page 51