Favourable opinion for reimbursement in the treatment of multiple myeloma (for more details, see MA).
What therapeutic improvement?
No clinical added value compared to DARZALEX 20 mg/mL concentrate for solution for infusion.
Role in the care pathway?
The role of DARZALEX 1,800 mg solution for subcutaneous injection (daratumumab) is identical to that of DARZALEX 20 mg/mL concentrate for solution for infusion. It is a first or second-line treatment for multiple myeloma, used in combination with various treatment regimens. Its role as monotherapy from the third line of treatment for multiple myeloma remains to be defined.
Clinical Benefit
Substantial
The clinical benefit of DARZALEX 1,800 mg solution for injection (daratumumab) is substantial in the MA indications.
Clinical Added Value
no clinical added value
Considering:
demonstration of the non-inferiority of daratumumab as monotherapy by the subcutaneous route compared to administration by the IV route, in terms of overall response rate and pharmacokinetics, demonstrated in an open-label study in patients with relapsed or refractory multiple myeloma, and the methodological reservations raised,
the absence of demonstrated improvement in terms of progression-free survival and overall survival in patients with relapsed or refractory multiple myeloma and the absence of data concerning these criteria in the other indications of DARZALEX (daratumumab),
the similar safety profile between the two administration routes, apart from the superiority of SC administration of daratumumab compared to IV administration in terms of infusion-related reactions, demonstrated in this same study,
the absence of a demonstrated impact in terms of improvement of quality of life in patients with relapsed or refractory multiple myeloma due to a lack of robust data, and the absence of data concerning this criterion in the other indications of DARZALEX (daratumumab), and despite a subcutaneous administration regimen compared to IV infusion,
the Transparency Committee considers that DARZALEX 1,800 mg solution for injection (daratumumab) provides no clinical added value (CAV V) compared to DARZALEX 20 mg/mL concentrate for solution for infusion.
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