TECVAYLI (teclistamab) - Multiple myeloma

The Committee deems that the clinical benefit of TECVAYLI (teclistamab) 10 mg/mL or 90 mg/mL solution for injection remains substantial in the MA indication.

Considering:

• efficacy data from a phase 1/2 non-comparative study, with an overall response rate of 62% (CI95%: [53.7%; 69.8%]) in a life-threatening situation,
• uncertainties concerning the clinical relevance of the primary endpoint used (overall response rate) and its transposability to overall survival time or improvement of quality of life,
• uncertainties with respect to the specific effect size of this treatment, considering the methodological weaknesses of indirect comparisons,
• the safety profile marked by significant haematotoxicity, the occurrence of cytokine release syndrome (CRS), of low grade in the majority of cases, and a risk of infection (infections with atypical microorganisms),
• uncertainties with respect to the clinical efficacy and safety in the longer term,
• the benefit of having access to a medicinal product having been assessed following the failure of prior therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody,

the Committee deems that, based on the current data, and pending the findings of the MajesTEC-3 randomised phase 3 study in particular, TECVAYLI (teclistamab) 10 mg/mL or 90 mg/mL solution for injection provides no clinical added value (CAV V) in the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.