Reason for request

Extension of indication

-


Clinical Benefit

Substantial

The  actual  benefit  of ABRAXANE in combination with gemcitabine is substantial in the extension of indication “first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas”


Clinical Added Value

minor

ABRAXANE in combination with gemcitabine provides  a  minor  improvement  in  actual  benefit  (level  IV)  compared  with gemcitabine monotherapy in the treatment of metastatic adenocarcinoma of the pancreas, in adult patients, as first-line treatment.