KYMRIAH (tisagenlecleucel) - diffuse large B-cell lymphoma (DLBCL)

Considering all these elements, the Committee deems that the clinical benefit of KYMRIAH 1.2 x 10^6 – 6 x 10^8 cells (tisagenlecleucel) dispersion for infusion remains substantial in “the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy” and at the MA dosages.

Considering:

• additional experience with respect to the real-world data for KYMRIAH (tisagenlecleucel) in the French DESCAR-T registry (26 activated centres, 388 treated patients, median follow-up of 15 months since eligibility), which are consistent with the clinical data (JULIET),
• the role of KYMRIAH (tisagenlecleucel) compared to YESCARTA (axicabtagene ciloleucel), which remains difficult to determine given the major methodological limitations of the indirect comparison provided,
• the safety profile marked by significant short-term toxicity,
• and the initial uncertainties identified, which persist despite the Transparency Committee’s requests, particularly with respect to:
  • the exact effect size compared to historic management, in the absence of any robust comparison,
  • maintenance of the clinical efficacy in the medium and long term, particularly concerning achievement of full recovery for patients in lasting remission,
  • and the absence of medium and long-term safety data,

The Committee considers that its previous conclusions are not liable to be modified. On the basis of currently available data, the Committee deems that KYMRIAH 1.2 x 10^6 – 6 x 10^8 cells (tisagenlecleucel) dispersion for infusion provides a minor clinical added value (CAV IV) in terms of efficacy compared to the historic management of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy, based on various chemotherapies.