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”
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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.
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