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Reason for request
Key points
Favourable opinion for reimbursement in combination with bortezomib and dexamethasone in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
What therapeutic improvement?
No clinical added value compared to the bortezomib / dexamethasone combination.
Role in the care pathway?
There is no standard treatment for the first relapse or progression of multiple myeloma. The therapeutic decision depends on age, previous treatments, the duration of the first remission, the circumstances of the relapse, the general health status of patients and their comorbidities.
Role of the medicinal product in the care pathway
IMNOVID in combination with bortezomib and dexamethasone is a second line and later-line treatment for adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Clinical Benefit
| Substantial |
The clinical benefit of IMNOVID (pomalidomide) is substantial in the MA indication “in combination with bortezomib and dexamethasone in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide”.
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Clinical Added Value
| no clinical added value |
IMNOVID, in combination with bortezomib and dexamethasone, provides no clinical added value (CAV V) compared to the bortezomib / dexamethasone combination, in patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
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