DARZALEX (daratumumab), anticorps monoclonal
ONCOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jan 31 2019
Reason for request
Extension of indication
High clinical benefit combined with lenalidomide/dexamethosone, or bortezomib/dexamethosone bitherapy, for multiple myeloma in patients having already received at least one previous treatment, and minor clinical added value compared to each of these bitherapies used alone
DARZALEX has been granted marketing authorisation, in combination with lenalidomide and dexamethosone, or with bortezomib and dexamethosone, for the treatment of adults suffering from multiple myeloma and having received at least one prior treatment.
The efficacy of these combinations is based primarily on progression-free survival results and response rates, though with no demonstrated gain in overall survival or quality of life.
Pending overall survival data, DARZALEX, combined with a lenalidomide/dexamethosone or bortezomib/dexamethosone bitherapy, provides minor clinical added value compared to each of the bitherapies used alone in the treatment of multiple myeloma, after at least one prior treatment.
Clinical Benefit
Substantial |
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Clinical Added Value
minor |
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-
Economic analysis
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